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ACADIA Pharmaceuticals to Present Phase 2 CLARITY Results for Pimavanserin as an Adjunctive Treatment in Major Depressive Disorder at the 2019 American Psychiatric Association Annual Meeting

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SAN DIEGO–(BUSINESS WIRE)–ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company
focused on the development and commercialization of innovative medicines
to address unmet medical needs in central nervous system disorders,
today announced it will present data from its Phase 2 CLARITY study,
which evaluated the efficacy, safety, and tolerability of pimavanserin
as an adjunctive treatment for major depressive disorder (MDD) at the
2019 American Psychiatric Association Annual Meeting in San Francisco,
May 18 – 22, 2019.

Poster Presentation
Poster:
#P8-049
Date/Time: Tuesday, May 21, 2:00 p.m. – 4:00 p.m. Pacific
Time
Title: CLARITY: A Phase 2 Double-blind, Placebo-controlled
Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in
Major Depressive Disorder

The Phase 2 CLARITY study was a 10-week, randomized, double-blind,
placebo-controlled, multi-center, two-stage sequential parallel
comparison design study that evaluated the efficacy, safety, and
tolerability of pimavanserin (34 mg once daily). Pimavanserin was
administered as an adjunctive treatment in patients with MDD who had an
inadequate response to a stable dose of standard antidepressant therapy
with either a selective serotonin reuptake inhibitor (SSRI) or a
serotonin norepinephrine reuptake inhibitor (SNRI). The study randomized
207 patients across 27 clinical research centers in the U.S. and was
conducted in collaboration with the Massachusetts General Hospital (MGH)
Clinical Trials Network and Institute.

There is a significant need for new therapies for the majority of
patients suffering from major depressive disorder who do not respond to
initial antidepressant therapy,” said Professor Maurizio Fava, M.D.,
Executive Vice Chair, Department of Psychiatry, MGH, Director of the
Division of Clinical Research of the MGH Research Institute, and
Associate Dean for Clinical & Translational Research, Harvard Medical
School. “The results observed in the Phase 2 CLARITY study combined with
a favorable tolerability profile provides evidence that adjunctive
treatment with pimavanserin may provide meaningful benefit to those MDD
patients who have an inadequate response to either a SSRI or a SNRI
therapy.”

In the trial, pimavanserin met the overall primary endpoint of the
weighted average results of Stage 1 and Stage 2 by significantly
reducing the 17-item Hamilton Depression Rating Scale total score
compared to placebo (p=0.039). On the key secondary endpoint,
pimavanserin demonstrated statistically significant reductions compared
to placebo in the Sheehan Disability Scale score (p=0.004). Positive
results were also observed for seven other secondary endpoints,
including improvement in daytime sleepiness as measured by the
Karolinska Sleepiness Scale and improvement in sexual function as
measured by the Massachusetts General Hospital Sexual Functioning Index.

In this Phase 2 study of pimavanserin as an adjunctive treatment for
MDD, we found patients treated with pimavanserin experienced significant
reduction in their depression symptoms in addition to improvement in
daytime sleepiness and sexual function when compared to placebo,” said
Serge Stankovic, M.D., M.S.P.H., ACADIA’s President. “These results are
encouraging for patients with MDD who may experience challenges with
their current treatment options. We look forward to further evaluating
pimavanserin as an adjunctive treatment in our ongoing Phase 3 CLARITY
program.”

On April 25, ACADIA
announced
it had initiated its Phase 3 CLARITY program for
pimavanserin as an adjunctive treatment for MDD. The CLARITY-2 study
will be based in the U.S. and has already initiated enrollment and the
CLARITY-3 study will be based outside the U.S. and will initiate
enrollment in the upcoming months. Both studies are six-week,
parallel-designed, randomized, double-blind, placebo-controlled,
multi-center studies designed to evaluate the efficacy and safety of
pimavanserin as adjunctive treatment in patients with MDD who have an
inadequate response to standard antidepressant therapy with either a
SSRI or a SNRI.

About Major Depressive Disorder
According to the National
Institute of Mental Health, MDD affects approximately 16 million adults
in the U.S.1, with approximately 2.5 million adults treated
with adjunctive therapy.2,3 MDD is a condition characterized
by depressive symptoms such as a depressed mood or a loss of interest or
pleasure in daily activities for more than two weeks, as well as
impaired social, occupational, or other important functioning. The
majority of people who suffer from MDD do not respond adequately to
initial antidepressant therapy.4

About Pimavanserin
Pimavanserin is a selective serotonin
inverse agonist and antagonist preferentially targeting 5-HT2A
receptors. These receptors are thought to play an important role in
depression, psychosis, and other neuropsychiatric disorders. ACADIA is
evaluating pimavanserin in an extensive clinical development program
across multiple indications with significant unmet need including
dementia-related psychosis, schizophrenia inadequate response,
schizophrenia-negative symptoms, and MDD. Pimavanserin was approved for
the treatment of hallucinations and delusions associated with
Parkinson’s disease psychosis by the U.S. Food and Drug Administration
in April 2016 under the trade name NUPLAZID®. NUPLAZID is not
approved for the adjunctive treatment of patients with MDD.

About ACADIA Pharmaceuticals
ACADIA is a
biopharmaceutical company focused on the development and
commercialization of innovative medicines to address unmet medical needs
in central nervous system disorders. ACADIA has developed and
commercialized the first and only medicine approved for the treatment of
hallucinations and delusions associated with Parkinson’s disease
psychosis. ACADIA also has ongoing clinical development efforts in
additional areas with significant unmet need, including dementia-related
psychosis, schizophrenia inadequate response, schizophrenia-negative
symptoms, major depressive disorder, and Rett syndrome. This press
release and further information about ACADIA can be found at: www.acadia-pharm.com.

Forward-Looking Statements
Statements in this press release
that are not strictly historical in nature are forward-looking
statements. These statements include, but are not limited to, statements
related to: the potential benefits of pimavanserin as adjunctive
treatment for MDD or other central nervous system disorders as well as
the potential results of clinical trials of pimavanserin in other
indications. These statements are only predictions based on current
information and expectations and involve a number of risks and
uncertainties. Actual events or results may differ materially from those
projected in any of such statements due to various factors, including
the risks and uncertainties inherent in drug development, approval and
commercialization, and the fact that past results of clinical trials may
not be indicative of future trial results. For a discussion of these and
other factors, please refer to ACADIA’s annual report on Form 10-K for
the year ended December 31, 2018 as well as ACADIA’s subsequent filings
with the Securities and Exchange Commission. You are cautioned not to
place undue reliance on these forward-looking statements, which speak
only as of the date hereof. This caution is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. All
forward-looking statements are qualified in their entirety by this
cautionary statement and ACADIA undertakes no obligation to revise or
update this press release to reflect events or circumstances after the
date hereof, except as required by law.

Important Safety Information and Indication for
NUPLAZID (pimavanserin)

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS

  • Elderly patients with dementia-related psychosis treated with
    antipsychotic drugs are at an increased risk of death.
  • NUPLAZID is not approved for the treatment of patients with
    dementia-related psychosis unrelated to the hallucinations and
    delusions associated with Parkinson’s disease psychosis.
  • Contraindication: NUPLAZID is contraindicated in patients with
    a history of a hypersensitivity reaction to pimavanserin or any of its
    components. Rash, urticaria, and reactions consistent with angioedema
    (e.g., tongue swelling, circumoral edema, throat tightness, and
    dyspnea) have been reported.
  • QT Interval Prolongation: NUPLAZID prolongs the QT interval.

    • The use of NUPLAZID should be avoided in patients with known QT
      prolongation or in combination with other drugs known to prolong
      QT interval including Class 1A antiarrhythmics or Class 3
      antiarrhythmics, certain antipsychotic medications, and certain
      antibiotics.
    • NUPLAZID should also be avoided in patients with a history of
      cardiac arrhythmias, as well as other circumstances that may
      increase the risk of the occurrence of torsade de pointes and/or
      sudden death, including symptomatic bradycardia, hypokalemia or
      hypomagnesemia, and presence of congenital prolongation of the QT
      interval.
  • Adverse Reactions: The most common adverse reactions (≥2% for
    NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%),
    nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs
    3%), constipation (4% vs 3%), and gait disturbance (2% vs
  • Drug Interactions:

    • Coadministration with strong CYP3A4 inhibitors (e.g.,
      ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to
      10 mg taken orally as one tablet once daily.
    • Coadministration with strong or moderate CYP3A4 inducers reduces
      NUPLAZID exposure. Avoid concomitant use of strong or moderate
      CYP3A4 inducers with NUPLAZID.

Indication: NUPLAZID is indicated for the treatment of
hallucinations and delusions associated with Parkinson’s disease
psychosis.

Dosage and Administration: Recommended dose: 34 mg capsule taken
orally once daily, without titration.

NUPLAZID is available as 34 mg capsules and 10 mg tablets.

Please see the full Prescribing
Information
including Boxed WARNING for NUPLAZID.

References
1National Institute of Mental Health.
(2017). Major Depression. Retrieved from http://www.nimh.nih.gov/health/statistics/major-depression.shtml.

2IMS NSP, NPA, NDTI MAT-24 month data through Aug-2017.

3PLOS One, Characterization of Treatment Resistant Depression
Episodes in a Cohort of Patients from a US Commercial Claims
Database, Oct 2013, Vol 8, Issue 10.

4Rush AJ, et al. (2007) Am J. Psychiatry 163:11, pp.
1905-1917 (STAR*D Study).

Contacts

Investor Contact:
ACADIA Pharmaceuticals Inc.
Mark
Johnson, CFA
(858) 261-2771
[email protected]

Media Contact:
ACADIA Pharmaceuticals Inc.
Maurissa
Messier
(858) 768-6068
[email protected]


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Cannabis

Cannabis Capsule Global Analysis Report 2024: Market to Reach $79.2 Billion in 2028 – Forecast to 2033 Featuring GW Pharmaceuticals, Trulieve Cannabis, Green Thumb Industries, Tilray, Columbia Care

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Innocan

Innocan Pharma Initiates FDA Approval Process for Liposome Injection Therapy for Chronic Pain

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With its submission of a Pre-IND Meeting Request Letter, Innocan initiates the regulatory process with the U.S. Food and Drug Administration (FDA) for the approval of its prolonged CBD release technology for human use

HERZLIYA, Israel and CALGARY, AB, April 22, 2024 /PRNewswire/ — Innocan Pharma Corporation (CSE: INNO) (FSE: IP4) (OTCQB: INNPF) (“Innocan” or the “Company”), is pleased to announce that is has reached a key milestone: the Company submitted its letter of application for a Pre-IND meeting, the first phase in the FDA approval process in the United States for Innocan’s Liposome-Cannabidiol (LPT-CBD) injectable treatment of chronic pain.

With the global market for pain therapeutics widely expected to exceed US$100 billion by 2032[1], LPT therapy which requires only one single monthly subcutaneous injection, is positioned as a highly attractive alternative to opioid-based approaches. Opioids have and continue to take a significant human toll in recent years, with more than three-quarters of drug overdose deaths in the United States involving opioids, according to the United States Center for Disease Control and Prevention[2].

Innocan’s therapy has shown consistent efficacy in multiple pre-clinical trials in recent years of it’s LPT-CBD injectable treatment through prolonged and controlled release of CBD in animals with chronic pain conditions. Innocan’s Pre-IND Meeting Request Letter to the FDA is a key milestone and important first step in seeking approval of its LPT-CBD therapy for use in humans. At the Pre-IND meeting, the objective will be to obtain guidance from the FDA on the preclinical and clinical development plan, enabling the initiation of an Investigational New Drug (IND) program in the United States.

Iris Bincovich, CEO of Innocan, commented: “We are extremely excited to embark on this next stage in the development of LPT-CBD injectables, this is a major Milestone for Innocan Pharma. We have invested significant effort and many thousands of person-hours in its research and development, accumulating a wealth of preclinical data that will serve as the foundation for our participation in the FDA process. This is a key milestone for Innocan and marks our first step towards the FDA’s recognition of our technology. We see significant potential for our therapy, with an addressable market for pain management therapeutics expected to exceed US $100 billion by 2032, and we look forward to tapping that.

Dr. Joseph Pergolizzi, Innocan’s FDA Advisory Board Member, added:

“We have worked hard to catalogue the data collected as part of our animal LPT therapy testing program and prepare it for the FDA. We look forward to working under FDA guidance, with the goal of completing the review process as quickly and efficiently as possible. We believe that Innocan’s unique treatment method, if and when it should become FDA-approved has the potential of being a highly valuable non-opioid addition in the medical arsenal of the management of chronic pain.”

About Innocan

Innocan is a pharmaceutical tech company that operates under two main segments: Pharmaceuticals and Consumer Wellness. In the Pharmaceuticals segment, Innocan focuses on developing innovative drug delivery platform technologies based on advanced cannabinoids science, to treat various conditions to improve patients’ quality of life. This segment involves two drug delivery technologies: (i) LPT CBD- loaded liposome platform facilitating exact dosing and the prolonged and controlled release of CBD into the blood stream. The LPT delivery platform research is in the preclinical trial phase for: Pain Management. In the Consumer Wellness segment, Innocan develops and markets a wide portfolio of innovative and high-performance self-care products to promote a healthier lifestyle. Under this segment, Innocan has established a joint venture by the name of BI Sky Global Ltd. that focuses on advanced targeted online sales. https://innocanpharma.com/

For further information, please contact:

For Innocan Pharma Corporation:
Iris Bincovich, CEO

+1-516-210-4025

+972-54-3012842

+442037699377
[email protected]

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

Cautionary note regarding forward-looking information

Certain information set forth in this news release, including, without limitation, information regarding research and development, collaborations, the filing of potential applications with the FDA and other regulatory authorities, the potential achievement of future regulatory milestones, the potential for treatment of conditions and other therapeutic effects resulting from research activities and/or the Company’s products, requisite regulatory approvals and the timing for market entry, is forward-looking information within the meaning of applicable securities laws. By its nature, forward-looking information is subject to numerous risks and uncertainties, some of which are beyond Innocan’s control. The forward-looking information contained in this news release is based on certain key expectations and assumptions made by Innocan, including expectations and assumptions concerning the anticipated benefits of the products, satisfaction of regulatory requirements in various jurisdictions and satisfactory completion of requisite production and distribution arrangements.

Forward-looking information is subject to various risks and uncertainties which could cause actual results and experience to differ materially from the anticipated results or expectations expressed in this news release. The key risks and uncertainties include but are not limited to: general global and local (national) economic, market and business conditions; governmental and regulatory requirements and actions by governmental authorities; and relationships with suppliers, manufacturers, customers, business partners and competitors. There are also risks that are inherent in the nature of product distribution, including import / export matters and the failure to obtain any required regulatory and other approvals (or to do so in a timely manner) and availability in each market of product inputs and finished products. The anticipated timeline for entry to markets may change for a number of reasons, including the inability to secure necessary regulatory requirements, or the need for additional time to conclude and/or satisfy the manufacturing and distribution arrangements. As a result of the foregoing, readers should not place undue reliance on the forward-looking information contained in this news release concerning the timing of launch of product distribution. A comprehensive discussion of other risks that impact Innocan can also be found in Innocan’s public reports and filings which are available under Innocan’s profile at www.sedar.com.

Readers are cautioned that undue reliance should not be placed on forward-looking information as actual results may vary materially from the forward-looking information. Innocan does not undertake to update, correct or revise any forward looking information as a result of any new information, future events or otherwise, except as may be required by applicable law.

[1] https://www.gminsights.com/industry-analysis/pain-management-drugs-market

[2] https://www.cdc.gov/opioids/data/index.html

Logo – https://mma.prnewswire.com/media/2046271/3968398/Innocan_Pharma_Corporation_Logo.jpg

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Curaleaf

Curaleaf Completes Acquisition of Northern Green Canada

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Bolsters Company’s Advantage in Several Key Emerging Markets, including Australia, New Zealand, Germany, Poland and the United Kingdom

NEW YORK, April 22, 2024 /PRNewswire/ — Curaleaf Holdings, Inc. (TSX: CURA) (OTCQX: CURLF) (“Curaleaf” or the “Company”), a leading international provider of consumer cannabis products, announced today the closing of its acquisition of Northern Green Canada (“NGC”), a vertically integrated Canadian licensed cannabis producer focused primarily on expanding in the international market through its EU-GMP certification. The accretive acquisition amplifies the Company’s strategic advantage in established European markets including Germany, Poland and the United Kingdom and provides a foothold in the emerging markets of Australia and New Zealand.

Integrating NGC’s international operation will equip Curaleaf with a secure and consistent high quality, non-irradiated, indoor EU-GMP flower supply, essential to maintaining its leading positions in Germany, the United Kingdom and Poland.

“We are thrilled to welcome NGC formally to the Curaleaf family of global brands,” said Boris Jordan, Founder and Executive Chairman of Curaleaf. “This is an incredibly important deal for our international expansion strategy, as we’ll be able to bolster our supply of high quality EU-GMP certified flower immediately to key European markets as well as enter the fast-growing markets of Australia and New Zealand.”

The global cannabis market is projected to generate $55 billion in sales by 2027. Emerging markets beyond the United States and Canada, including Germany, Australia and New Zealand are expected to contribute $6.3 billion of the $55 billion projection.

Terms of the acquisition of NGC include an initial payment at closing of the Company’s Subordinate Voting Shares valued at approximately US $16 million, subject to a typical post-closing adjustment. An earnout may also be paid in 2025 based upon 2024 performance of NGC’s operations, up to 50% of which will be cash and the rest paid in additional Subordinate Voting Shares. The issuance of Subordinate Voting Shares in connection with the acquisition of NGC has been conditionally approved by the Toronto Stock Exchange, subject to fulfilling customary listing conditions.

About Curaleaf Holdings
Curaleaf Holdings, Inc. (TSX: CURA) (OTCQX: CURLF) (“Curaleaf”) is a leading international provider of consumer products in cannabis with a mission to enhance lives by cultivating, sharing and celebrating the power of the plant. As a high-growth cannabis company known for quality, expertise and reliability, the Company and its brands, including Curaleaf, Select, Grassroots, JAMS, Find and Zero Proof provide industry-leading service, product selection and accessibility across the medical and adult use markets. Curaleaf International is the largest vertically integrated cannabis company in Europe with a unique supply and distribution network throughout the European market, bringing together pioneering science and research with cutting-edge cultivation, extraction and production. Curaleaf is listed on the Toronto Stock Exchange under the symbol CURA and trades on the OTCQX market under the symbol CURLF. For more information, please visit https://ir.curaleaf.com.

Forward Looking Statements
This media advisory contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward–looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans”, “expects” or, “proposed”, “is expected”, “intends”, “anticipates”, or “believes”, or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. More particularly and without limitation, this news release contains forward-looking statements and information concerning the expected benefits of the acquisition of NGC, and the Company’s planned expansion on internal markets, the Company’s anticipated strategic advantages in European markets and emerging markets, the integration of NGC’s internal operations, the anticipated global cannabis market, and the listing of shares issuable in connection with the acquisition on the Toronto Stock Exchange. Such forward-looking statements and information reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company with respect to the matters described in this new release, including the Company’s ability to successfully realize the expected benefits of the acquisition, and the Company’s ability to fulfil the listing conditions imposed by the Toronto Stock Exchange. Forward-looking statements involve risks and uncertainties, which are based on current expectations as of the date of this release and subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements, including the failure to realize the expected benefits of the acquisition, or the Company’s failure to fulfil the listing conditions imposed by the Toronto Stock Exchange. Additional information about these assumptions and risks and uncertainties is contained under “Risk Factors and Uncertainties” in the Company’s latest annual information form filed on March 6, 2024, which is available under the Company’s SEDAR profile at http://www.sedar.com, and in other filings that the Company has made and may make with applicable securities authorities in the future. Forward-looking statements contained herein are made only as to the date of this press release and we undertake no obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. The Toronto Stock Exchange has not reviewed, approved or disapproved the content of this news release.

INVESTOR CONTACT
Curaleaf Holdings, Inc.
Camilo Lyon, Chief Investment Officer
[email protected]

MEDIA CONTACT
Curaleaf Holdings, Inc.
Tracy Brady, SVP Corporate Communications
[email protected]

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