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Methylnaltrexone
The investigational drug methylnaltrexone is being developed to treat opioid-induced constipation and post-operative ileus, debilitating medical conditions. In addition, methylnaltrexone has received FDA Fast Track designation for postoperative ileus for which there are no approved medications. In December 2005, Wyeth and Progenics entered into a license and co-development agreement for the development and commercialization of methylnaltrexone.
Opioids medications, such as morphine, are widely used to relieve pain and act by activating mu-opioid receptors located in the central nervous system - the brain and spinal cord. Opioids, however, also interact with these receptors outside of the central nervous system, resulting in serious side effects, including constipation, urinary retention and severe itching. These side effects often prevent optimal pain control or prolong hospitalization. Methylnaltrexone is designed to block peripheral opioid receptors whose activation causes these side effects. As methylnaltrexone is restricted from crossing the human blood-brain barrier, it does not interfere with brain-centered pain relief.
Methylnaltrexone is being developed in three different dosage forms and routes of administration, which we believe will represent a significant benefit to patients and health care professionals. Each methylnaltrexone dosage form is tailored to address the needs of specific clinical applications based on onset of action, predictability of response, dosing flexibility and ease of use. The three methylnaltrexone product candidates are:
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Methylnaltrexone Subcutaneous Injection for the treatment of opioid-induced constipation in patients receiving palliative care for advanced cancer, AIDS, cardiopulmonary disease and other painful terminal illnesses. Many of those treated with opioids for pain suffer debilitating constipation.
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Methylnaltrexone Oral Formulation for the treatment of opioid-induced constipation in patients with chronic pain, including those suffering from headaches, joint pain, lower-back pain, sickle-cell disease, muscle pain and other disorders requiring opioid analgesics.
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Methylnaltrexone Intravenous Infusion for the treatment post-operative ileus, a dysfunction of the gastrointestinal tract that commonly occurs after major abdominal and prolonged surgeries. Post-operative ileus delays recovery and can prolong hospitalization, as patients are typically not discharged until bowel function is restored. Intravenous methylnaltrexone has been designated for Fast Track status by the U.S. Food and Drug Administration (FDA). 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.