Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) and Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP ) today announced the successful outcome of the Phase 3 trial to evaluate the efficacy and safety of oral methylnaltrexone for the treatment of opioid-induced constipation (OIC) in subjects with chronic, non-cancer pain.
The trial whichwas designed to evaluate three once-daily oral methylnaltrexone dosing regimens (150, 300 and 450mg), demonstrated highly statistically significant results for the primary endpoint in two of the three treatment arms when compared to the placebo treatment arm.
Both the 300 and 450 mg treatment arms demonstrated highly statistically significant improvements in rescue-free bowel movement (RFBM) within 4 hours of administration over 28 days of dosing when compared to placebo treatment.
In addition, the 300 and 450 mg treatment arms demonstrated highly statistically significant improvements in RFBM within 4 hours of administration following the first dose when compared to placebo treatment.
Overall, efficacy of oral methylnaltrexone in this study was comparable to that reported in clinical studies of subcutaneous methylnaltrexone in subjects with chronic, non-cancer pain. The overall observed safety profile seen in patients treated with oral methylnaltrexone was comparable to placebo in this study.
“We are extremely pleased with the outcome of this 804-subject Phase 3 trial of oral methylnaltrexone in the treatment of opioid-induced constipation in subjects with chronic, non-cancer pain,” stated Bill Forbes, Pharm.D., Executive Vice President, Medical and R&D, and Chief Development Officer, Salix. “The results of this Phase 3 study show a clear dose response for oral methylnaltrexone. We look forward to presenting detailed data from this study at a medical conference in 2012, as well as submitting the New Drug Application (NDA) for this oral formulation mid-year 2012.”
“Subcutaneous methylnaltrexone, currently marketed as RELISTOR®, is an effective and well-tolerated therapy used to alleviate OIC in advanced illness patients receiving opioids for pain,” said Robert J. Israel, M.D., Progenics’ Senior Vice President for Medical Affairs. “We believe an oral dosage form, if approved, could help patients suffering from OIC resulting from opioid treatment for their chronic pain.”
In addition, as we told our readers previously, in late August, Progenics and their partner Salix Pharmaceuticals, announced that the FDA had accepted for filing a supplemental New Drug Application for Relistor Subcutaneous Injection to treat opioid-induced constipation (OIC) in patients with non-cancer pain. The FDA has issued a PDUFA action date of April 27, 2012.
Today's announcements add a couple of new 2012 milestone catalyst
entires to our FDA Calendar and Regulatory Catalyst Calendar for Progenics, who's clinical programs are focused on gastroenterology, virology, and oncology areas. Its Relistor® (methylnaltrexone bromide) is used for the treatment of opioid-induced constipation (OIC). It selectively displaces opioids from the mu-opioid receptors outside the CNS, including those located in the gastrointestinal tract, thereby decreasing their constipating effects.
Progenics' product pipeline includes: Methylnaltrexone indicated for the treatment of opioid-induced constipation and post-operative ileus, debilitating medical conditions; PRO 140, a humanized monoclonal antibody designed to block HIV infection by inhibiting the virus' ability to bind to and enter immune system cells; PSMA ADC an antibody-drug conjugate ("ADC") therapy for prostate cancer that binds to PSMA as well as to cells in the newly formed blood vessels of major solid tumors; PSMA Vaccines, are vaccines based on the prostate cancer biomarker, prostate-specific membrane antigen (PSMA), to induce antibodies to prostate cancer cells (PSMA subunit vaccine); HCV-entry inhibition based treatments of hepatitis C virus (HCV) infection; and others.
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