Forest Laboratories, Inc. to Present Data from Cariprazine & Levomilnacipran Phase 3 Trials at American Psychiatric Associati...
May 16 2013 - 8:00AM
Business Wire
Forest Laboratories, Inc. (NYSE: FRX), today announced it will
be presenting data on two late-stage development products,
cariprazine and levomilnacipran, at the American Psychiatric
Association (APA) annual meeting scheduled May 18-22, 2013, in San
Francisco, CA. Data on cariprazine, an investigational
antipsychotic agent, provides details from Phase 3 trials for
schizophrenia and acute mania in bipolar I disorder, as well as a
long-term safety and tolerability open-label study in patients with
bipolar I disorder. Separately, data on levomilnacipran, an
investigational agent for the treatment of adults with major
depressive disorder (MDD), includes additional analyses of phase 3
trial results. Forest anticipates decisions from the FDA on both
cariprazine and levomilnacipran within the calendar year.
The cariprazine results will be announced in six poster
presentations:
Clinical Posters
Monday, May 20 from 11:30 am - 1:00 pm PDT
- Efficacy and Safety of Low- and
High-Dose Cariprazine in Patients With Acute Mania Associated With
Bipolar I Disorder (NR8-03), authored by Joseph R. Calabrese,
MD
- Long-Term Safety and Tolerability of
Open-Label Cariprazine in Patients With Bipolar I Disorder
(NR8-26), authored by Terence A. Ketter, MD
- Cariprazine Effects on YMRS Items:
Results of a Pooled Analysis of 3 Randomized, Double-Blind,
Placebo-Controlled Trials in Bipolar Mania (NR8-13), authored
by Paul E. Keck, Jr., MD
Tuesday, May 21 from 9:00 am - 10:30 am PDT
- Cariprazine in Acute Exacerbation of
Schizophrenia: A Fixed-Dose Phase III, Randomized, Double-Blind,
Placebo- and Active-Controlled Trial (NR10-11), authored by
Andrew J. Cutler, MD
- Efficacy of Cariprazine on PANSS
Items and Marder Factors: Post Hoc Analysis of a Phase III,
Double-Blind, Placebo-Controlled Trial in Schizophrenia
(NR10-22), authored by John Kane, MD
Preclinical Poster
Tuesday, May 21 from 11:30 am - 1:00 pm PDT
- At Antipsychotic-Like Effective
Doses, Cariprazine Displays Potent Dopamine D3 and D2 Receptor
Occupancy In Vivo and Efficacy Across Animal Models (NR11-10),
authored by Nika Adham, PhD
The levomilnacipran results will be announced in eight poster
presentations:
Clinical Posters
Monday, May 20 from 2:00 pm - 4:00 pm PDT
- Effects of Levomilnacipran SR 40,
80, and 120 mg on Functional Outcomes in Major Depressive Disorder:
Post Hoc Analyses of a Phase III Trial (NR9-19), authored by
Carl Gommoll, MS
- Levomilnacipran SR Efficacy in Major
Depressive Disorder Across Patient Subgroups: Pooled Analyses of 5
Double-Blind, Placebo-Controlled Trials (NR9-29), authored by
Stuart Montgomery, MD
- Safety and Tolerability of
Levomilnacipran SR in Major Depressive Disorder: Results From An
Open-Label, 48-week Extension Study (NR9-43), authored by
Rajnish Mago, MD
- Cardiovascular Safety Profile of
Levomilnacipran SR in the Treatment of Major Depressive
Disorder (NR9-12), authored by Robert Palmer, MD
- Drug-Drug Interactions of
Levomilnacipran Sustained-Release Capsule With Ketoconazole,
Carbamazepine, or Alprazolam in Healthy Subjects (NR9-16),
authored by Laishun Chen
- Pharmacokinetic Characteristics of
Levomilnacipran Sustained-Released Capsule Following Single- and
Multiple-Dose Administration (NR9-37), authored by Laishun
Chen
Tuesday, May 21 from 9:00 am - 10:30 am PDT
- Safety and Tolerability of
Levomilnacipran SR in Major Depressive Disorder: Analysis of 5
Short-Term Double-Blind, Placebo-Controlled Trials (NR10-56),
authored by Michael E. Thase, MD
Preclinical Poster
Saturday, May 18 from 2:00 pm - 4:00 pm PDT
- Levomilnacipran (F2695), a
norepinephrine-preferring SNRI, improves working memory in the rat
delayed non-matching to position (DNMTP) assay (NR3-035),
authored by Ronan Depoortère, PhD
About Cariprazine
Forest has filed New Drug Applications (NDAs) with the U.S. Food
and Drug Administration (FDA) for cariprazine for the treatment of
schizophrenia and manic or mixed episodes associated with bipolar I
disorder. Cariprazine is an orally active and potent dopamine
D3-preferring D3 /D2 receptor partial agonist. Cariprazine has a
low affinity at other receptor sites such as 5-HT2C, muscarinic,
and adrenergic which have been associated with adverse events.
Cariprazine is also under development as an adjunctive treatment
for MDD and for the treatment of bipolar depression. Cariprazine
was discovered by Gedeon Richter Plc and is licensed to Forest
Laboratories Inc., in the U.S. and Canada.
About Levomilnacipran
Forest has filed a NDA with the FDA for levomilnacipran, a
serotonin norepinephrine reuptake inhibitor (SNRI) for the
treatment of Major Depressive Disorder (MDD) in adults.
Levomilnacipran (1S, 2R-milnacipran), an enantiomer of racemic
milnacipran, is protected by a method of use patent that extends
through June 2023, without patent term extension. An SNRI,
levomilnacipran has greater potency for norepinephrine reuptake
inhibition than for serotonin reuptake inhibition in vitro without
directly affecting the uptake of dopamine or other
neurotransmitters. Levomilnacipran has been developed as a
sustained-release formulation, dosed once daily. Levomilnacipran
was discovered by Pierre Fabre and is licensed to Forest
Laboratories, Inc., in the U.S. and Canada. Pierre Fabre will be
the active pharmaceutical ingredient supplier.
About Forest Laboratories, Inc.
Forest Laboratories' (NYSE: FRX) longstanding global
partnerships and track record developing and marketing
pharmaceutical products in the United States have yielded its
well-established central nervous system and cardiovascular
franchises and innovations in anti-infective, respiratory,
gastrointestinal and pain management medicine. Forest’s pipeline,
the most robust in its history, includes product candidates in all
stages of development across a wide range of therapeutic areas. The
Company is headquartered in New York, NY. To learn more, visit
www.FRX.com.
Except for the historical information contained herein, this
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. These
statements involve a number of risks and uncertainties, including
the difficulty of predicting FDA approvals, the acceptance and
demand for new pharmaceutical products, the impact of competitive
products and pricing, the timely development and launch of new
products, and the risk factors listed from time to time in Forest
Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form
10-Q, and any subsequent SEC filings. Forest assumes no obligation
to update forward-looking statements contained in this release to
reflect new information or future events or developments.
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