SAN DIEGO (AP) – Zogenix said its chronic pain treatment did well in a late-stage study. The drug developer expects to submit an application for approval for Zohydro to the Food and Drug Administration by early next year.
The San Diego company said the extended-release capsules led to significantly improved chronic pain relief compared to a placebo, and they were safe and well-tolerated.
Zohydro aims to treat moderate-to-severe chronic pain that requires around-the-clock opioid therapy for an extended period. Zogenix said Zohydro could become the first extended-release hydrocodone treatment available without acetaminophen, which comes with an increased risk of liver toxicity when used in high doses over time.
Zogenix said hydrocodone pain products represent the largest U.S. prescription drug category, with more than 131 million prescriptions filled last year. It said Zohydro’s ability to deliver hydrocodone over an extended time period without acetaminophen exposure will position it well in this market.
The company also is conducting a safety study on chronic pain patients and expects to complete that in the third quarter.
If approved, Zohydro would become the second commercial product for Zogenix. It also makes the migraine treatment Sumavel DosePro.
Date: August 17, 2011
Source: Associated Press
Filed Under: Drug Discovery