Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Alpharma, a global specialty pharmaceutical company, has announced that the FDA has advised the company that its new drug application for Embeda capsules has been accepted and designated for priority review.
Subscribe to our email newsletter
The priority review status provides for a review period of six months from the date of submission. The Embeda capsule new drug application was submitted on June 30, 2008.
The Embeda capsule is an investigational pharmacological extended release opioid in development for the relief of moderate to severe chronic pain.
Embeda capsules were developed using Alpharma’s proprietary technology, which is said to combine an extended-release opioid with sequestered naltrexone, an opioid antagonist.
Dean Mitchell, president and CEO of Alpharma, said: “We are pleased with the FDA’s decision to grant the Embeda capsule application a priority review and now anticipate the potential for an advisory panel meeting, where we can share the positive results from our Phase III clinical trials in the appropriate public forum.”