of efficacy for ALKS 5461 for the adjunctive treatment of major depressive disorder. ALKS 3831 ALKS 3831 is a novel, proprietary oral investigational medicine designed as an antipsychotic for the treatment of schizophrenia. ALKS 3831 includes samidorphan in combination with the antipsychotic drug olanzapine, which is generally available under the name ZYPREXA. ALKS 3831 is designed to provide the efficacy of olanzapine and a differentiated safety profile with favorable weight and metabolic properties and to have utility in the treatment of schizophrenia in patients with co-occurring alcohol use disorder. In January 2015, the company announced data from the first phase of a randomized, dose ranging, six-month phase 2 study of ALKS 3831 designed to assess the efficacy, safety and tolerability of ALKS 3831 in the treatment of schizophrenia and its attenuation of weight gain, compared to olanzapine. In April 2015, the company announced data from the completed, six-month, randomized, dose-ranging phase 2 study of ALKS 3831. In December 2015, the company announced the commencement of ENLIGHTEN-1, the first of two planned phase 3 studies from the ENLIGHTEN pivotal program for ALKS 3831. In February 2016, the company announced the initiation of ENLIGHTEN-2, a phase 3 study assessing weight gain with ALKS 3831 compared to olanzapine in patients with schizophrenia over a six month period. The company expects to use safety and efficacy data from the ENLIGHTEN pivotal program to serve as the basis for a New Drug Application to be submitted to the U.S. Food and Drug Administration, pending study results. ALKS 8700 ALKS 8700 is an oral, novel and proprietary monomethyl fumarate molecule in development for the treatment of multiple sclerosis. ALKS 8700 is designed to convert to monomethyl fumarate in the body and to offer differentiated features as compared to the marketed dimethyl fumarate, TECFIDERA. In May 2015, the company presented positive results from a phase 1, randomized, double-blind clinical study of ALKS 8700, designed to evaluate the safety, tolerability and single-dose pharmacokinetics of various oral formulations of ALKS 8700 compared to both placebo and active control groups. Following a meeting with the U.S. Food and Drug Administration, the company announced in October 2015 its plans to file a 505(b)(2) New Drug Application using pharmacokinetic bridging data from studies comparing ALKS 8700 and TECFIDERA and a two-year, multicenter, open-label study designed to assess the safety of ALKS 8700, which the company initiated in December 2015. Additionally, the company plans to initiate a randomized, head-to-head phase 3 study of the gastrointestinal tolerability of ALKS 8700 compared to TECFIDERA in mid-2016. In October 2015, the company also announced data from a randomized, double-blind phase 1 comparative pharmacokinetic study evaluating plasma monomethyl fumarate levels achieved by the administration of single doses of ALKS 8700 and TECFIDERA. The company would need to conduct additional preclinical studies and pharmacokinetic studies to further support pharmacokinetic comparability to TECFIDERA. The company expects to complete ALKS 8700 registrational studies and file the New Drug Application in 2018. ALKS 6428 ALKS 6428 is an oral formulation of naltrexone designed to help physicians transition patients from physical dependence on opioids to antagonist therapy. This transition process includes doses of naltrexone in conjunction with buprenorphine during a seven-day treatment period. Upon completion of the transition process, physicians would then be able to administer VIVITROL. In September 2015, the company initiated a phase 3 study evaluating the safety, tolerability and efficacy of ALKS 6428 in patients with opioid dependence. Aripiprazole Lauroxil Two-Month Dose Aripiprazole lauroxil is an injectable atypical antipsychotic, available as ARISTADA with once-monthly and six-week dosing options for the treatment of schizophrenia, in development with a two-month dosing interval. In February 2016, the company announced positive topline results from a randomized, open-
alkermes plc (8AK:Frankfurt)
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