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Shares in Alexza Pharmaceuticals climbed as much as 73 percent Tuesday after an FDA advisory panel voted 9-8, with one abstention, to recommend approval of Adasuve (Staccato loxapine) for the treatment of agitation in patients with schizophrenia or bipolar mania. The regulator is expected to make a final decision on whether to approve the inhaled drug by February 4.

The agency rejected Adasuve in October last year due to lung problems, including bronchial spasms, that may be fatal in people with conditions such as asthma or chronic obstructive pulmonary disorder, and the company resubmitted its application in August with a strategy to mitigate the risks. However, the panel of outside experts voted 17-1 that the risk strategy proposed by the company wouldn't be enough to mitigate the drug's side effects. Francis Becker, a medical officer in the FDA's division of psychiatry products, said Alexza's proposal didn’t resolve the agency’s concerns because it may be difficult for healthcare providers to identify respiratory distress in psychiatric patients who are "uncooperative and severely disorganised."

Instead, the panel members voted 11-5, with two abstentions, that Adasuve would have an acceptable safety profile if used as a single dose in 24 hours in conjunction with a risk evaluation and mitigation strategy (REMS) proposed by the FDA. "I think this product offers the potential to be a significant contribution to an important need," remarked advisory panel chairman Andrew Winokur, adding that "I think we've seen impressive efficacy data, and the aggressive REMS programme that the FDA has proposed is reassuring to me."

However, some panelists said even the FDA's proposed strategy would not be enough to ensure safety, and called for more studies prior to approval. "I feel like we really need to see a study in a more real-world situation, and I'm just not convinced yet," commented Elizabeth McCarthy, the consumer representative on the panel. "No regulatory precedent exists for a product that has this degree of bronchospasm as an adverse event," Theresa Michele, a medical officer in the FDA’s pulmonary products division, told the panel.

In clinical trials, Adasuve has been shown to start to work within 10 minutes of inhalation and was more effective than placebo in reducing agitation levels within two hours. FDA reviewers noted that although patients were noticeably calmer within 15 minutes after taking Adasuve, the drug hasn't been directly compared in studies to current treatments for agitation in people with schizophrenia and bipolar disorder. These injectable therapies include Eli Lilly's Zyprexa (olanzapine), Bristol-Myers Squibb's Abilify (aripiprazole) and Pfizer's Geodon (ziprasidone).

RBC Capital Markets analyst Jason Kantor suggested that if approved, Adasuve may generate annual sales of $150 million. The analyst noted that Alexza "would still need a US partner and/or to raise substantial cash to fund the launch of Adasuve, which should limit near-term upside."

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