— Results of Positive Phase 3 Study for Aripiprazole Lauroxil in Schizophrenia to be Presented —
— ALKS 3831 for the Treatment of Schizophrenia and Co-Occurring Alcohol Use, and ALKS 5461 for the Treatment of Major Depressive Disorder, Will Also be Highlighted —
Schizophrenia
Comprehensive data from the recently completed phase 3 study of aripiprazole lauroxil in patients with schizophrenia will be presented. The ASCP scientific committee has nominated this data presentation as a best poster, which will appear in the online 2014 ASCP Poster Session:
- Poster 75: Safety and Efficacy of Aripiprazole Lauroxil: Results From a Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Acute Exacerbation of Schizophrenia.
- The oral presentation, “Analysis and Missing Data Handling in Psychiatry Trials With Inevitable, High, Differential and Informative Discontinuations,” will be presented during a symposium entitled, “Statistical Methods, Personality Disorders, Substance Abuse, and Comorbidity Presentations.”
- Poster 73: Prevalence, Healthcare Utilization and Cost of Patients Dual Diagnosed With Schizophrenia and an Alcohol Use Disorder.
Depression
Data relating to ALKS 5461, the company’s development candidate for the treatment of major depressive disorder (MDD), will be presented. This presentation has also been nominated as a best poster, and will appear in the online 2014 ASCP Poster Session.
- Poster 44: ALKS 5461, a Novel Opioid Modulator as Adjunctive Treatment for Depression.
- Poster 26: Feasibility, Integrity and Efficiency of the Sequential Parallel Comparison Clinical Trial Design.
- Poster 27: Blinded Dual Ratings Confirm Primary Site-Based Ratings in an MDD Trial.
A full list of all
About Aripiprazole Lauroxil
Aripiprazole lauroxil, which utilizes Alkermes’ proprietary LinkeRx® technology, is an injectable atypical antipsychotic with one-month and two-month formulations in development for the treatment of schizophrenia. Once in the body, aripiprazole lauroxil converts to aripiprazole, which is commercially available under the name ABILIFY®.
About ALKS 5461
ALKS 5461 is a proprietary investigational oral medicine for the
treatment of major depressive disorder (MDD). ALKS 5461 is designed to
modulate the opioid system in the brain, employing a balanced
combination of agonist and antagonist components that act on opioid
receptors, and includes a novel opioid modulator, samidorphan,
discovered by
About ALKS 3831
ALKS 3831 is a proprietary investigational medicine designed as a broad-spectrum antipsychotic for the treatment of schizophrenia. ALKS 3831 is composed of samidorphan, a novel, potent mu-opioid antagonist, in combination with the established antipsychotic drug, olanzapine. ALKS 3831 is designed to attenuate olanzapine-induced metabolic side effects, including weight gain, and to have utility in patients with schizophrenia whose disease is exacerbated by alcohol use.
About
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended, including, but not
limited to, statements concerning the therapeutic value of our
investigational product candidates. The company cautions that
forward-looking statements are inherently uncertain. Although the
company believes that such statements are based on reasonable
assumptions within the bounds of its knowledge of its business and
operations, the forward-looking statements are neither promises nor
guarantees and they are necessarily subject to a high degree of
uncertainty and risk. Actual performance and results may differ
materially from those projected or suggested in the forward-looking
statements due to various risks and uncertainties. These risks and
uncertainties include those risks described in the
LinkeRx® is a registered trademark of
Source:
Alkermes
For Investors:
Rebecca
Peterson, +1-781-609-6378
or
For Media:
Jennifer Snyder,
+1-781-609-6166