Drug Discovery & Development - January 19, 2011
MOUNTAIN VIEW, Calif. (AP) - Shares of Alexza Pharmaceuticals Inc. sank after the company said it will file a new application for its drug candidate Adusuve Staccato in July.
Alexza expects the Food and Drug Administration to take six months to review its new submission. That means the agency could make a decision on Adusuve Staccato - the company's lead program - in early 2012.
In morning trading, shares of Alexza dropped 27 cents, or 16.2 percent, to $1.40.
Adusuve Staccato is an inhaled drug that is designed to treat agitation caused by schizophrenia or bipolar disorder. The FDA declined to approve the drug in October, citing concerns about the effects of the Staccato inhaler device has on patients' lungs. The agency also raised concerns about manufacturing issues. The company said Tuesday that the agency wants additional data related to the effects of the Staccato device on humans.
Alexza said the FDA said it wants it to develop a risk evaluation strategy and determine a way to identify patients who are at risk for pulmonary side effects.
Alexza is developing several other drugs that are administered through the Staccato device, including treatments for migraine headaches, panic attacks, severe pain, and insomnia.
Date: January 18, 2011
Source: Associated Press
Alexza expects the Food and Drug Administration to take six months to review its new submission. That means the agency could make a decision on Adusuve Staccato - the company's lead program - in early 2012.
In morning trading, shares of Alexza dropped 27 cents, or 16.2 percent, to $1.40.
Adusuve Staccato is an inhaled drug that is designed to treat agitation caused by schizophrenia or bipolar disorder. The FDA declined to approve the drug in October, citing concerns about the effects of the Staccato inhaler device has on patients' lungs. The agency also raised concerns about manufacturing issues. The company said Tuesday that the agency wants additional data related to the effects of the Staccato device on humans.
Alexza said the FDA said it wants it to develop a risk evaluation strategy and determine a way to identify patients who are at risk for pulmonary side effects.
Alexza is developing several other drugs that are administered through the Staccato device, including treatments for migraine headaches, panic attacks, severe pain, and insomnia.
Date: January 18, 2011
Source: Associated Press
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