The Food and Drug Administration has approved Alkermes long-acting injection treatment for schizophrenia.
The drug, called Aristada, which is similar to Otsuka’s Abilify, is an injection administered every month or every 6-weeks. In a 12-week Phase III trial, Aristada reportedly led to significant improvement for those with schizophrenia compared to those who took a placebo.
Alkermes plans to launch the new drug immediately, especially considering the schizophrenia treatment market is currently pretty congested. The FDA recently approved four generic versions of Abilify.
Alkermes believes Aristada is different enough that it will stand out, though. As Fierce Biotech reported, Aristada is the only schizophrenia medication designed for every-four-weeks and every-6-weeks dosing.
The company has other drugs in motion as well:
Aristada is emblematic of Alkermes’ guiding philosophy: taking established therapeutics and using new formulations or novel drug delivery to improve upon them. The company is at work on ALKS 3831, a Phase III take on the schizophrenia medicine olanzapine designed to duplicate that drug’s effect without the attendant weight gain. Alkermes is also moving forward with ALKS 8700, an oral multiple sclerosis treatment designed to compete with Biogen’s blockbuster Tecfidera, and the Phase III depression treatment ALKS 5461.
Photo: Flickr user Steven Depolo
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
