FDA whacks Alexza Pharma with CRL for Adasuve

Posted under Adasuve, Alexza Pharmaceuticals, Blog, Companies, Diagnostics, FDA, Funding, loxaprine, Medical Devices, Medical Supply, Pharmaceuticals, Regulatory, schizophrenia, Startups, Universities, Videos by rmcbride

Alexza Pharmaceuticals ($ALXA) was dealt another blow in its pursuit to gain approval of Adasuve from regulators. The FDA shot down the company's latest application because of manufacturing deficiencies related to the device used to take the inhaled antipsychotic drug, the company revealed last night.

The drug developer's shares tumbled 32.8% to 41 cents per share in pre-market trading.

U.S. regulators denied the company's application for Adasuve--a quick-acting inhaled version of the old drug loxaprine for outbursts from schizophrenia and manic episodes--in a complete response letter (CRL). The FDA stated in the CRL that manufacturing deficiencies would have to be addressed before Adasuve could be approved. Executives tried to put a positive spin on the CRL, pointing out that no new safety or clinical issues cropped up in the letter. But as biotech commentator Adam Feuerstein indicated on Twitter, that doesn't tell investors whether regulators felt that the company had resolved previous safety concerns. 

Adasuve promises patients with schizophrenia and biopolar I the benefits of easy administration and fast activity of loxaprine, The Wall Street Journal reported. Yet the inhaled version of the drug has raised concerns about its potentially deadly pulmonary effects and the risks associated with improper use of the treatment. Despite those concerns, the drug narrowly passed muster late last year in an FDA advisory panel's 9-8 vote to back approval. Yet the glow from that small victory quickly vanished when the FDA said in January that its decision on approval would be delayed by three months.

Alexza executives plan to address the CRL in a conference call this morning, no doubt in an effort to reassure investors that a way forward exists for the troubled program. The CRL also brought up the issue of Adasuve's product labeling and a REMS plan that has been proposed to limit potential dangers of the treatment, yet the details of those items were murky in the company's release.

- here's the release
- see the WSJ report

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Alexza readies "significant" layoffs, brings in Lazard to review asset sale

Posted under Adasuve, Alexza Pharmaceuticals, Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Just days after eking out an FDA expert panel vote in favor of its inhaled antipsychotic Adasuve, Alexza Pharma ($ALXA) has brought in Lazard to investigate the possible sale of assets as it prepares to drop the budget axe on an uncertain number of employees.

Mountain View, CA-based Alexza announced that Lazard would look at a "possible sale or disposition of one or more corporate assets, a strategic business combination, partnership or other transactions." And the biotech said that it would "significantly reduce" its workforce as it pushed for a formal agency approval. Alexza shares were largely unaffected by the news this morning, with the stock trading at 66 cents.

An expert FDA committee voted 9 to 8 in favor of Adasuve on December 12, with a number of critics clearly remaining unhappy with the safety issues that have hobbled the program before. That vote came after investors dumped shares in Alexza after reading regulators' concerns about the potentially lethal pulmonary effects of the treatment in patients with asthma or COPD. Those same risks persuaded the FDA to reject Alexza's initial try at an approval. But a majority of the FDA panel felt that the biotech's risk mitigation strategy, which would demand that patients are carefully screened and then monitored for the first hour after treatment, satisfied their safety concerns.

- here's the press release
- read the Bloomberg report

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Alexza shares spike after antipsychotic wins weak embrace from FDA panel

Posted under Adasuve, Alexza Pharmaceuticals, Bipolar disorder, Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, schizophrenia, Startups, Universities, Videos by John Carroll

Alexza Pharma ($ALXA) just barely managed to clear one of the big hurdles that threatened to once again block its marathon effort at winning an FDA approval of the inhaled antipsychotic treatment Adasuve (formerly AZ-004). An expert FDA committee voted 9 to 8 in favor of an approval yesterday evening, with a number of critics clearly remaining unhappy with the safety issues that have hobbled the program before.

Just days ago investors were dumping shares in Alexza after reading regulators' concerns about the potentially lethal pulmonary effects of the treatment in patients with asthma or COPD. Those same risks persuaded the FDA to reject Alexza's initial try at an approval. But a majority of the FDA panel felt that the biotech's risk mitigation strategy, which would demand that patients are carefully screened and then monitored for the first hour after treatment, satisfied their safety concerns.

"This product offers the potential to be a significant contributor to an important need," noted Andrew Winokur, director of psychopharmacology at the University of Connecticut School of Medicine in Farmington, according to a report from Bloomberg. Alexza provided "impressive efficacy data."

Adasuve is a vaporized version of the old antipsychotic loxapine. Inhaling it with the use of a new device developed by Alexza offers a quick method for dealing with bouts of schizophrenia and bipolar mania. But a number of specialists in the FDA remain worried that the drug could wind up in the wrong hands, or administered without all the necessary precautions.

Investors, who have alternately fled and embraced Alexza's shares, initially responded to the positive vote by pushing its battered shares up more than 70%. By mid-morning some of those gains had been given up as analysts considered Alexza's chances at finally winning an approval from a skeptical FDA. Some analysts say an approval could pave the way to a market worth about $150 million in annual revenue.

Alexza now faces a PDUFA deadline on February 4.

- read the press release
- here's the report from Bloomberg

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Posted under Adasuve, Alexza Pharmaceuticals, Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, schizophrenia, Startups, Universities, Videos by Ryan McBride

Investors appeared to get worried after FDA staffers cited worries about lung safety issues with Alexza Pharmaceuticals' ($ALXA) inhaled anti-agitation drug Adasuve. Shares of the developers stock were down 47.47% yesterday, with the safety concerns potentially slimming the odds that the drug will gain U.S. approval for patients with schizophrenia or bipolar disorder as hoped early next year.

Pulmonary safety risks were among the concerns that sunk Alexza's last attempt to gain FDA approval of the drug in fall 2010. The recent FDA staff review said the drug appeared to be effective in reducing agitation in patients, but the reviewers were unsatisfied that the company had answered lingering questions about the risk of airway threats to patients who take the treatment, Reuters reported.

Alexza's drug offers the convenience of an inhaled therapy for a condition that now gets treated with a menu of injected drugs, and bringing the therapy quickly into the bloodstream via the lungs could also be beneficial, yet regulators have a track record of harping on safety issues of drugs despite such advantages. With the harsh critique of the drug in the FDA staff review, investors appeared to flee from Alexza's stock ahead of a Feb. 4 action date on the developer's application for approval.

But if the FDA approval of the sleep drug Intermezzo--a reformulated Ambien treatment that was twice rejected by the agency--taught us anything last month, persistence and perseverance in drug development can pay off eventually.

- check out Reuters' coverage
- and Bloomberg's article

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