One of the most interesting candidates in Alkermes’ (ALKS) pipeline is aripiprazole lauroxil for schizophrenia. The candidate performed well in a phase III study. Results from the study were presented by the company at the American Society of Clinical Psychopharmacology. The randomized, multicenter, double-blind, placebo-controlled study evaluated the efficacy, safety and tolerability of the candidate (once a month) across two doses (441 mg and 882 mg) in patients with acute exacerbation of schizophrenia.
Data from the study during the double-blind treatment period revealed statistically and clinically significant reduction in patients’ total scores compared to placebo on the Positive and Negative Syndrome Scale (:PANSS) following 12 weeks of treatment with aripiprazole lauroxil across both the evaluated doses. With this the candidate met the primary objective of the study. PANSS, a psychiatric scale, measures the symptom severity in schizophrenia.
Furthermore, treatment with aripiprazole lauroxil resulted in improvement from baseline in the Clinical Global Impression – Improvement Scale at week 12. All other key secondary endpoints of the study were also met. The candidate was found to be well tolerated in the study. Alkermes stated in its press release that all patients who participated in the study were eligible to continue with aripiprazole lauroxil for an additional 12 months to asses the safety and long-term durability of the treatment.
Aripiprazole lauroxil, an atypical antipsychotic, is converted into aripiprazole once it enters into the patient's body. We note that aripiprazole is marketed by Bristol-Myers Squibb Company (BMY)/ Otsuka under the trade name Abilify.
Encouraged by the positive phase III data, Alkermes intends to seek U.S. approval of the schizophrenia candidate in the third quarter of 2014.The approval would boost Alkermes' top line since the schizophrenia market offers significant commercial potential. Alkermes is also evaluating aripiprazole lauroxil so that it can be dosed once every two months.
Alkermes, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Better-ranked biopharma stocks include Gilead Sciences (GILD) and Regeneron Pharmaceuticals (REGN). Both the stocks carry a Zacks Rank #1 (Strong Buy).