Forest Laboratories, Inc. 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
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