TARRYTOWN, N.Y., March 30 (UPI) -- Progenics filed a new drug application with the U.S. Food and Drug Administration for methylnaltrexone for opioid-induced constipation.
If the drug gets approved, Progenics and its marketing partner Wyeth plan to launch single-use vials in early 2008, followed by pre-filled syringes.
"While opioids are the mainstay for the treatment of pain in patients receiving palliative care in the United States, the side effects of these medications can be significant for many patients," said Bernard Poussot, Wyeth's president, chief operating officer and vice chairman.
"Because methylnaltrexone has the potential to address a major gastrointestinal side effect of opioid therapy, this NDA submission is an important development and a major milestone in Wyeth's collaboration with Progenics," Poussot added.
"The submission of our first New Drug Application to the FDA is our most significant corporate achievement to date and one that could lead to the availability of a potential breakthrough therapy for palliative care patients suffering from opioid-induced constipation," said Paul Maddon, Progenics' founder, CEO and chief science officer.
