Alkermes (company)

Alkermes plc is a biopharmaceutical company that focuses on central nervous system (CNS) diseases. The company is the result of a merger in September 2011 between Alkermes, Inc. and Elan Drug Technologies (EDT), the former drug formulation and manufacturing division of Élan Corporation, plc. The company is headquartered in Dublin, and has an R&D center in Waltham, Massachusetts and manufacturing facilities in Athlone, Ireland; Gainesville, Georgia; and Wilmington, Ohio.

Products

Alkermes has more than 20 commercial drug products and candidates that address serious and chronic diseases such as addiction, schizophrenia, diabetes and depression. Among these, five products are primary to the company: risperidone long-acting Injection (generic for Risperdal Consta) for schizophrenia and bipolar 1 disorder,paliperidone palmitate (generic for Invega Sustenna in the U.S., Xeplion in Europe) for schizophrenia,4-aminopyridine (generic for Ampyra in the U.S., Fampyra in Europe) to improve walking in patients with multiple sclerosis,naltrexone for extended-release injectable suspension (generic for Vivitrol) for alcohol and opioid dependence, and exenatide extended-release for injectable suspension (generic for Bydureon) for the treatment of type 2 diabetes. Bydureon is a once-weekly, extended-release form of the drug, exenatide (Byetta), and was developed through a partnership between Amylin Pharmaceuticals, Alkermes and Eli Lilly. It is approved in Europe and the U.S.

Aripiprazole lauroxil

Aripiprazole lauroxil (USAN) (brand name Aristada) is a long-acting injectable atypical antipsychotic that was developed by Alkermes. It is an N-acyloxymethyl prodrug of aripiprazole that is administered via intramuscular injection once every four to six weeks for the treatment of schizophrenia. Aripiprazole lauroxil was approved by the U.S. FDA on 5 October 2015.

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Samidorphan

Samidorphan (INN, USAN) (developmental code names ALKS-33, RDC-0313), also known as 3-carboxamido-4-hydroxynaltrexone, is an opioid antagonist that selectively blocks the μ-opioid receptor, without blocking the δ-opioid or κ-opioid receptors. It has been investigated for the treatment of alcoholism and cocaine addiction by its developer, Alkermes, showing similar efficacy to naltrexone but possibly with reduced side effects.

However, it has attracted much more attention as part of the combination product ALKS-5461, where samidorphan is combined with the mixed μ-opioid agonist and κ-opioid antagonist opioid modulator buprenorphine, as an antidepressant. Buprenorphine has shown antidepressant effects in some human studies, thought to be because of its antagonist effects at the κ-opioid receptor, but has not been further developed for this application because of its μ-opioid agonist effects and consequent abuse potential. By combining buprenorphine with samidorphan to block the μ-opioid agonist effects, the combination acts more like a selective κ-opioid antagonist, and produces only antidepressant effects, without typical μ-opioid effects being evident.