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January 31, 2007 - Reuters (US)

"Smokable" Pain Drugs Promise Faster Action

By Toni Clarke

Return to Drug War News: Don't Miss Archive

BOSTON (Reuters) - All self-respecting painkillers these days offer "fast-acting relief," a promise we accept to mean anywhere from 15 minutes to more than an hour.

For Alexza Pharmaceuticals Inc., which is developing drugs for migraine, pain, panic and agitation, "fast" has to mean "within seconds."

The Palo Alto, California-based company is developing drugs that can be "smoked," and, like nicotine in cigarettes, pass through the lungs and into the bloodstream almost instantly.

Investors like the idea.

Alexza's shares have risen nearly 60 percent over the past five months, dramatically outperforming the Nasdaq Biotechnology Index, which rose 15 percent over the same period.

"What makes this an exciting story is how broadly applicable the technology could prove to be," said Charles Duncan, an analyst at JMP Securities, which helped take the company public for $8 a share a year ago.

Alexza was formed by biotechnology entrepreneur Alejandro Zaffaroni, who also founded nicotine-patch developer Alza. His latest venture is not the only company that is developing inhaled therapies: Nektar Therapeutics and Alkermes Inc. develop powdered insulin.

But Alexza's idea of heating up a drug to create a vapor, or smoke, is unique.

The company's lead product is a vaporized version of an old drug called prochlorperazine, which Alexza is developing for migraine headaches but is currently used in liquid, oral or suppository form to treat severe nausea.

While it is sometimes given intravenously in hospitals to treat patients with acute migraines, the drug is inconvenient to deliver.

Hip Flask Inhalers

Alexza is hoping to provide similar results but in such a way that patients can carry the delivery device -- an inhaler that looks like a miniature hip flask -- in a pocketbook or the glove compartment of a car.

The device contains a battery-powered package that heats a thin coating of drug to create a vapor that can be sucked into the lungs.

"It's a useful mode of delivery, though its desirability and frequency of prescription will depend on the disorder," said Dr. Jeffrey Lieberman, chairman of psychiatry at Columbia University.

The company plans to release initial results of a mid-stage clinical trial of its migraine drug by the end of March. If all goes according to plan, Alexza could file a marketing application with U.S. regulators in 2010.

The company is also testing inhalable drugs for pain and anxiety, and for agitation in schizophrenia patients.

While Lieberman doubts there would be much demand for an inhaled product for agitated schizophrenia patients, who would be unlikely to cooperate in taking it, he said there could be benefit for patients with migraine, panic and pain.

"People with panic disorder want immediate relief and would be very cooperative," Lieberman said. "They know that if they take a pill it can take up to an hour to work. This would be a non-stigmatizing way to deal with the situation."

Thomas King, Alexza's chief executive, said the company expects to announce a partnership with either a major drugmaker or specialty pharmaceuticals or device company to help develop at least one drug during the second half of this year.

"The key is to find partners with the same passion for the technology and what it conveys as we do," he said.

© Reuters 2007. All rights reserved.

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