Alkermes Looks To FDA For Approval Of Schizophrenia Drug

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About: Alkermes plc (ALKS)
by: Terry Chrisomalis
Summary

Alkermes achieved positive results from its second phase 3 study known as ENLIGHTEN-2, where those who took ALKS 3831 saw a reduction in weight gain compared to current SOC olanzapine.

The company expects to file an NDA for FDA approval of ALKS 3831 treating patients with schizophrenia by mid-2019.

The first phase 3 efficacy study for ALKS 3831, known as ENLIGHTEN-1, already had achieved the primary efficacy endpoint based on the PANSS compared to placebo.

Recently, Alkermes Plc (ALKS) announced results from its second phase 3 study treating patients with schizophrenia. These next set of results will allow the company to file a New Drug Application (NDA) for FDA approval by mid 2019. The reduced amount of weight gain for those taking ALKS 3831 over olanzapine is very intriguing. Alkermes may face some challenges moving forward, but the drug has a good shot at being approved regardless.

Pushing The Envelope

The phase 3 trial is known as ENLIGHTEN-2 and it recruited a total of 561 patients with schizophrenia. The objective was to evaluate the weight gain for those on ALKS 3831 compared to those on olanzapine over a six-month period. Patients were randomized 1:1 to receive either ALKS 3831 or olanzapine. The co-primary endpoints of this study were percent change from baseline in body weight at six months, and the proportion of patients with a 10% or more weight gain from baseline at six months. The first co-primary endpoint of mean percent change from baseline body weight at six months was met. That's because those patients in the olanzapine treatment group had a 57% higher mean percentage weight change at six months compared to those patients taking ALKS 3831. In other words, those taking ALKS 3831 didn't gain as much weight in the study compared to those who took olanzapine. The other co-primary endpoint of proportion of patients who gained 10% or more of baseline body weight at six months also was met. That's because patients in the olanzapine group had 29.8% of patients who gained 10% or more from baseline. On the other hand, only 17.8% of patients treated with ALKS 3831 obtained higher than 10% or more weight gain. This was an important study that breaks down to one key issue. That key issue being that olanzapine works great as an anti-psychotic, but the problem is the increase in weight patients obtain by taking it. In my opinion, having a drug like ALKS 3831 would definitely be used to counter the weight issue associated with olanzapine. The study shown is the second phase 3 for the ENLIGHTEN program. The first phase 3 study already proved efficacy as the primary endpoint was met in the ENLIGHTEN-1 study. This study showed that patients treated with ALKS 3831 achieved statistically significant reductions from baseline in the Positive and negative Syndrome Scale (PANSS) scores compared to placebo. This was obtained with a statistically significant p-value of p <0.001. Alkermes expects to file an NDA application for approval of ALKS 3831 by mid-2019.

Making Up Lost Ground

Alkermes desperately needed something good for its pipeline, and the latest results for ALKS 3831 in schizophrenia should definitely help. The reason why I state that is because it recently ran into a problem with its depression drug ALKS-5461. About a month ago, an FDA advisory panel noted that ALKS-5461 didn't show enough evidence that the drug is effective for the target population. It voted 21 to 2 that the results provided do not support approval of the drug for depression. The FDA won't make its decision until Jan. 31, 2019. However, the FDA tends to have a more favorable agreement with its advisory panel. Considering that the vote was heavily toward rejecting approval, I don't see the FDA going against its advisory panel. The good news is that ALKS 3831 for treating schizophrenia may be a huge redeeming factor for Alkermes, especially after its major setback for its depression drug.

Conclusion

I believe that ALKS 3831 for treating patients with schizophrenia should be a good start toward Alkermes redeeming itself after the negative panel vote for the depression drug. There are two major risks associated with ALKS 3831. The first is that the FDA has not yet approved the drug. That means there's no guarantee that it will be approved by the FDA based on the current data. Although I feel as if it does have a good shot at eventually being approved. The other major risk involves generics, which are based at lower prices. That's because it's hard to say if ALKS 3831 will be used over generics, which tend to be cheaper. The appeal is that patients will likely want to take Alkermes' drug over the generics because of the reduce weight gain. The key issue is whether or not insurers will pay for the higher-priced drug over the generic one. Until a price is released for the final drug, it's a little too early to tell at this point in time on market success.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.