alkermes plc (ALKS) Key Developments
Alkermes Announces Positive Results from Phase II Schizophrenia Study
Jan 14 15
Alkermes plc has announced positive results from the 12-week, randomized, double-blind, active-controlled, dose-ranging stage of a Phase II study of ALKS 3831, an investigational, oral atypical antipsychotic drug candidate designed to be a broad-spectrum treatment for schizophrenia. ALKS 3831 is composed of samidorphan, a novel, potent mu-opioid antagonist, in combination with the established antipsychotic drug, olanzapine. Data from the 300-patient study showed that ALKS 3831 achieved the study's primary efficacy endpoint, demonstrating equivalence to olanzapine in reduction from baseline in Positive and Negative Syndrome Scale (PANSS) total scores at Week 12.
Alkermes plc Announces Positive Results from Study of ALKS 5461 for Treatment of Depressive Disorder
Jan 6 15
Alkermes plc announced top line results from FORWARD-1, one of a series of supportive clinical studies in the comprehensive FORWARD phase 3 pivotal program for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD). The FORWARD-1 study was designed to evaluate the safety and tolerability of two titration schedules of ALKS 5461. In addition, the study assessed the efficacy of ALKS 5461 over an eight-week period, compared to baseline, in patients with MDD. Data from the 66-patient study showed that ALKS 5461 was generally well tolerated in both of the two titration schedules evaluated one-week and two-week dose escalation schedules. The most common adverse events in the study were nausea, constipation and dry mouth. These findings were consistent with the safety and tolerability profile seen in the 142-patient phase 2 study completed in 2013. Additionally, the exploratory efficacy analyses showed that ALKS 5461 significantly reduced depressive symptoms from baseline starting at Week One and continued to the end of the treatment period at Week Eight in patients who received either of the two titration schedules. The observed changes from baseline were clinically meaningful and statistically significant (pFORWARD-1 Study Design). The primary objective of the study was to evaluate the safety and tolerability of the two titration schedules for ALKS 5461. Efficacy endpoints, including the change in Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline and the Clinical Global Impression “Severity Scale (CGI-S) score at Week Eight, were assessed in exploratory analyses. All participants in the double-blind portion of the study were eligible to continue in an open-label phase and receive ALKS 5461 for an additional 12 months. The objective of the extension phase of the study is to assess the safety and long-term durability of effect of ALKS 5461.
Alkermes plc Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-13-2015 07:30 AM
Jan 6 15
Alkermes plc Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-13-2015 07:30 AM. Venue: Westin St. Francis Hotel, San Francisco, California, United States. Speakers: Richard F. Pops, Chairman of the Board and Chief Executive Officer.
Alkermes plc Announces Initiation of Clinical Study of Extended Durations of Aripiprazole Lauroxil for Treatment of Schizophrenia
Dec 15 14
Alkermes plc announced the initiation of a phase 1 clinical study of extended dosing intervals of aripiprazole lauroxil, the company’s investigational, novel, long-acting injectable atypical antipsychotic for the treatment of schizophrenia. The randomized, open-label study of approximately 140 patients with schizophrenia will evaluate the pharmacokinetics, safety and tolerability of aripiprazole lauroxil administered over two new extended durations – once every six weeks, and once every two months. A New Drug Application (NDA) for aripiprazole lauroxil one-month is currently under review with the U.S. Food and Drug Administration (FDA) and has been assigned a Prescription Drug User Fee Act (PDUFA) date of Aug. 22, 2015. The phase 1, randomized, open-label study will evaluate the pharmacokinetics, safety and tolerability of aripiprazole lauroxil when administered at one-month, six-week and two-month intervals. Following a 30-day screening period, approximately 140 patients with stable schizophrenia will be randomized to receive one of four different dosing regimens of aripiprazole lauroxil (441 mg once per month, 882 mg every six weeks, or one of two formulations of 1,064 mg every two months) for a total of six treatment months. Results from this phase 1 study are expected mid 2016.
Alkermes plc Presents at NASDAQ OMX 31st Investor Program, Dec-02-2014 10:45 AM
Nov 25 14
Alkermes plc Presents at NASDAQ OMX 31st Investor Program, Dec-02-2014 10:45 AM. Venue: The Waldorf Hilton, Aldwych, London, WC2B 4DD, United Kingdom.