Allergan's Vraylar needs 'negative' success to stand out in the antipsychotic crowd

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Allergan's new launch Vraylar may have a chance in the crowded antipsychotic market, if it can shine at treating schizophrenia's “negative” symptoms, such as lack of emotion and loss of interest in everyday activities. But one analyst isn’t holding his breath.

In surveying 25 docs who have already prescribed the March roll-out, Bernstein’s Ronny Gal found that only 6 considered Vraylar better than its in-class competitors at treating negative symptoms. And “given that this is an early adopter population, we would have hoped for higher excitement rate,” he wrote in a note to clients.

Of course, the numbers could reflect an “early experience bias,” he noted; not all patients have issues with negative symptoms, and some who do may need more time on the drug before they begin to show improvement.

For now, though, “we would argue Vraylar is yet to prove itself as differentiated on negative symptoms,” he wrote, predicting the med would likely fall short of its blockbuster potential and cap out at $500 million in 2022 sales.

Just what makes efficacy in negative symptoms so crucial to Vraylar’s success? One word: differentiation. No other antipsychotic has proved effective at treating those symptoms, so there’s a big opportunity to stand out in a crowd that already includes generics of former giants such as Otsuka’s Abilify, AstraZeneca’s Seroquel and Johnson & Johnson’s Risperdal.

Allergan is more hopeful about its chances of doing so. Vraylar posted a statistically significant improvement in negative symptoms in one Phase III trial in Europe, and the drugmaker has said it’s targeting the first half of next year to apply for a label expanded to include that fact.

Of course, even if it can snag the FDA nod, Allergan will still have reimbursement hurdles to deal with, Gal pointed out. While good efficacy and tolerability as a second- or third-line choice may have made for blockbuster numbers 5 years ago, the cost-containment pressure in today’s environment makes for a different story. 68% of the doctors he queried said payer issues have already kept their patients from getting their hands on the med.

Allergan commercial chief Bill Meury was upbeat about the drug’s future on the company’s second-quarter conference call, though, forecasting that the number of prescribing psychiatrists would hit 10,000 by year’s end.

“We do see a changing of the guard over time in this market with new atypicals replacing the older ones,” he said. “The future of Vraylar can be described as nothing but very promising.”

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