Progenics Pharmaceuticals Inc and Wyeth Pharmaceuticals, a division of Wyeth, announced that Progenics is submitting a New Drug Application (NDA) for marketing approval to the US Food and Drug Administration (FDA) for the subcutaneous formulation of methylnaltrexone for the treatment of opioid-induced constipation (OIC) in patients receiving palliative care.
Methylnaltrexone is a peripherally acting opioid-receptor antagonist that is designed to treat OIC without interfering with pain relief.
Opioid analgesics are commonly prescribed to manage pain in patients with advanced illness. Some experts have stated that, in the palliative care setting, constipation occurs in practically all patients on opioid therapy. There currently is no approved medication that specifically targets the underlying cause of OIC to relieve constipation in this patient population.
"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," says Bernard Poussot, president, chief operating officer and vice chairman, Wyeth. "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."
The NDA submission is based on data from two phase 3 studies that evaluated the safety and efficacy of the subcutaneous formulation of methylnaltrexone in the treatment of OIC in patients receiving palliative care. All of the primary efficacy endpoints of the studies were positive and statistically significant, and the therapy was generally well tolerated. Based on these results, Progenics is submitting the NDA and expects a standard review cycle. A standard review cycle enables the companies to submit additional data during the review period to support a shelf life of up to 18 months at launch for the room-temperature-stable formulation. Pending FDA approval, Progenics and Wyeth plan to launch single-use vials in early 2008.
Later in 2008, the companies plan to introduce methylnaltrexone in pre-filled syringes.
"This is a historic and gratifying milestone not only for Progenics and everyone who successfully executed and participated in the clinical trials but also for those working to advance and enhance the care of these seriously ill patients," says Paul J. Maddon, PhD., Progenics' founder, CEO and chief science officer. "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."