Endo has entered into a licensing agreement that gives it exclusive North American clinical development and commercialization rights to Alexza Pharmaceuticals' AZ-003 for treating breakthrough pain in cancer and noncancer patients, the firms announced Dec. 28.

AZ-003 is a hand-held device that employs Alexza's proprietary Staccato inhalation technology to deliver fentanyl. The electrically heated, multiple dose inhaler generates excipient-free fentanyl aerosol for deep lung delivery.

Clinical data indicates that "AZ-003 could potentially have a rapid onset of action comparable to intravenous administration," Endo CEO Peter Lankau pointed out.

During a Phase I clinical trial with 50 opioid-naive healthy volunteers, the AZ-003 PK was equivalent to the intravenous fentanyl PK, with similar peak plasma concentration, time to maximum plasma concentration and area under the curve concentration, Alexza reported at the American Society of Anesthesiologists meeting in October.

"We have 100 percent bioavailability," Alexza CEO Thomas King explained during a Dec. 28 investor conference call.

Like a patient-controlled IV pump, the AZ-003 limits dosing, King said. Alexza also is investigating several methods to prevent tampering - a patient ID code, RFID chip keyed to a patient bracelet or necklace, and biometric readers.

The licensing agreement calls for Endo to pay Palo Alto, Calif.-based Alexza an upfront fee of $10 million. Additional payments for achieving predetermined regulatory milestones could total $40 million. Royalties will be based on net sales.

Endo immediately will assume responsibility for remaining clinical trial development and regulatory filings. Alexza is responsible for completing development of the device.

FDA approval of AZ-003 will be pursued through an NDA, King said. Because AZ-003 is a combination product, portions of the NDA will be submitted to the Center for Devices and Radiological Health for consultation, but approval will come from CDER, he noted.

The Staccato technology also is in clinical development for delivering prochlorperazine to treat migraines, loxapine to treat acute agitation in schizophrenia, and alprazolam to treat acute panic attacks.

-Cathy Dombrowski (c.dombrowski@elsevier.com)

Endo Gains Alexza’s Inhalation Therapy To Deliver Fentanyl For Pain Treatment

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