Alkermes plc ALKS announced positive top-line results from ALPINE (Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness), a six-month phase IIIb study evaluating the efficacy, safety and tolerability of its long-acting injectable Aristada (aripiprazole lauroxil) and Johnson & Johnson's JNJ monthly injectable Invega Sustenna (paliperidone palmitate) in 200 patients experiencing acute exacerbations of schizophrenia .
In the study, both Aristada, given every two months, and Invega Sustenna, given every month, demonstrated statistically significant improvements from baseline in schizophrenia symptoms. The study also showed that the efficacy was similar for both medicines throughout the six-month study .
The study met its pre-specified primary endpoint, with both medications demonstrating statistically significant reductions in Positive and Negative Syndrome Scale (PANSS) total scores at Week 4. Scores were down 17.4 points for the Aristada group and 20.1 points for the Invega Sustenna group. Improvements in PANSS total scores were not statistically different between the groups in any assessment during the course of the study.
The research proves that these two long-acting medicines, each with their own distinct safety and tolerability profile, may be clinically useful to bridge the critical transition between inpatient and outpatient settings of care. The results showed that that long-acting atypical antipsychotics can help in rapidly and effectively stabilizing patients in the hospital and supporting their continuity of care after discharge.
We remind investors that the two-month Aristada extended-release injectable suspension is marketed for the treatment of schizophrenia. Also, Aristada Initio extended-release product is marketed for the treatment of schizophrenia in adults.
Shares of Alkermes have rallied 24.5% in the past year compared with the industry’s growth of 9.9%.
The company is also developingALKS 3831, which is currently in phase III for the treatment of schizophrenia.
Other players in the schizophrenia treatment market include AstraZeneca plc's AZN Seroquel XR, Johnson & Johnson's Risperdal Consta and Allergan’s AGN Vrylar.
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Alkermes currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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