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Alkermes schizophrenia drug shines in Phase III

Published on 08/04/14 at 01:30pm
Aripiprazole lauroxil converts to the molecule in Abilify once in the body

Alkermes’ investigational schizophrenia drug has met its primary endpoint in a pivotal trial, leading the firm to seek regulatory approval in the US.

Results from the Phase III study of aripiprazole lauroxil, a once-monthly atypical antipsychotic for the treatment of schizophrenia, shows that the drug achieved statistically significant reductions from baseline in Positive and Negative Syndrome Scale (PANSS) total scores at week 12, compared to placebo.

The PANSS is standard a medical scale used for measuring symptom severity of patients with schizophrenia, with level 1 seeing symptoms ‘absent’, and the highest level 7 having symptoms diagnosed as ‘severe’.

The company did not say, however, what score the patients achieved on its medicine.

Based on the positive results from this late-stage study, Alkermes plans to submit a New Drug Application to the FDA in the third quarter.

“These statistically significant efficacy data demonstrate aripiprazole lauroxil’s ability to provide clinically meaningful symptom control in patients struggling with schizophrenia,” says Henry Nasrallah, chair of the department of neurology and psychiatry at Saint Louis University School of Medicine.

He adds: “A once-monthly version of aripiprazole with multiple dose strengths would be a welcome addition since it would enhance current treatment options and provide dosing flexibility.

“These data come at a time when the treatment landscape for schizophrenia is evolving; more [doctors] are now recognising the benefits of long-acting injectable antipsychotics and considering their use earlier in disease progression.”

In addition to meeting the primary efficacy endpoint, the study also met its secondary endpoint of improvement on the Clinical Global Impression – Improvement scale (CGI-I) versus placebo at week 12.

Richard Pops, chief executive of Alkermes, explains: “Our goal has been to develop a differentiated long-acting injectable product candidate responsive to the real-world needs of patients and healthcare providers, providing the proven efficacy of aripiprazole administered once-monthly in a ready-to-use format with multiple dosage strengths.

“With these positive data in hand, we will complete the preparation of our NDA, which we plan to submit next quarter, and continue our preparations to bring this important new medicine to patients and healthcare providers.”

Growing market

Aripiprazole lauroxil is a new, long-acting injectable antipsychotic agent designed to provide patients with once-monthly dosing of a medication that, once in the body, converts to aripiprazole.

This is the molecule used in the already approved Abilify, developed and marketed by Otsuka Pharmaceuticals, Lundbeck and Bristol-Myers Squibb, which has licenses for bipolar disorder, depression and schizophrenia.

The Abilify brand made nearly $6 billion in sales last year, making it one of the biggest selling drugs in the world. But this is with three licences and the might of the BMS marketing machine – Alkermes’ new drug, should it get to market, will most likely not be bringing in that sort of revenue.

However, Alkermes has said that the company’s market data suggests that long-acting medications are still ‘underutilised in many markets’, and will hope to capitalise on this gap.

The Ireland-based firm will present more data from the Phase III study at an upcoming medical meeting, and also submit the results for publication in a peer-reviewed journal, it says in a statement.

An estimated 2.4 million Americans have schizophrenia, with men and women affected equally.

Worldwide, it is estimated that one person in every 100 develops schizophrenia, one of the most serious types of mental illness.

Ben Adams

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