Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 Wyeth, Progenics Get Fast Track | Contract Pharma

What are you searching for?

Sign in

Wyeth, Progenics Get Fast Track

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

Wyeth Pharmaceuticals, a division of Wyeth, and Progenics Pharmaceuticals have received Fast Track designation from the FDA for their application of the intravenous form of methylnaltrexone, which is being investigated for the treatment of postoperative ileus. The FDA Fast Track designation facilitates development and expedites regulatory review of drugs that the FDA recognizes to potentially address an unmet medical need for serious or life-threatening conditions.

Methylnaltrexone is an investigational drug that is being studied as a treatment for the peripheral side effects of opioid analgesics that does not affect the pain relief provided by these analgesics. Methylnaltrexone is being developed in three dosage forms: subcutaneous and oral forms as treatment platforms for opioid-induced constipation, and an intravenous form for postoperative ileus. In December 2005, Wyeth and Progenics Pharmaceuticals entered into a collaboration agreement to develop and commercialize methylnaltrexone.

The Fast Track designation will allow the companies to submit the NDA on a rolling basis, and also to request priority review, cutting the review period from 10 months to six.

Progenics has completed a Phase II study of intravenous methylnaltrexone showing accelerated gastrointestinal recovery in patients following segmental colectomies. In the 2006 third quarter, Wyeth and Progenics plan to initiate global Phase III studies in patients at high risk for developing postoperative ileus. An NDA submission is planned for the intravenous form in late 2007 or early 2008.

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters