October 2007
Patient Enrollment Complete in Study of Nalbuphine ER
Posted 10/29/07
Patient enrollment in a Phase IIa trial of nalbuphine extended release (ER), a treatment for chronic pain, has been completed. The randomized, double-blind, placebo-controlled trial will evaluate the analgesic efficacy of Nalbuphine ER. Approximately 135 patients with chronic pain secondary to osteoarthritis of the knee or hip will enroll in the trial. Preliminary results are expected to be available in the first quarter of 2008.
Results of CRx-102 Trial Published
Posted 10/29/07
The Annals of the Rheumatic Diseases has published the results of CombinatoRx CRx-102 Phase IIa hand osteoarthritis trial. CRx-102 was found effective at reducing pain in hand osteoarthritis. A Phase IIb trial, COMET-1, to evaluate the efficacy of CRx-102 in subjects with symptomatic knee osteoarthritis has now begun. CRx-102 also will be tested in rheumatoid arthritis in the Phase IIb MARS-1 study, set to begin in the fourth quarter.
Zingo Meets Primary Endpoint
Posted 10/17/07
Positive top-line results were reported from the Phase III trial of Zingo in patients undergoing venipuncture or intravenous line placement. Roughly half of the 699 adult participants received the Zingo (lidocaine hydrochloride monohydrate) injection system while the rest took placebo one to three minutes before undergoing medical procedures. The study met its primary endpoint, demonstrating less venous procedural pain in those treated with Zingo. Zingo is currently approved by the FDA to provide local analgesia prior to venipuncture or peripheral intravenous cannulation in children age 3 to 18 years. A supplemental new drug application will likely be filed with the FDA the first quarter of 2008 for indication in adults.
Back Pain Trial to Begin Soon
Posted 10/17/07
A protocol agreement for the Phase III clinical trial of NMED-1077 for the treatment of chronic pain has been reached with the FDA. The randomized withdrawal, placebo-controlled, double-blind NMED-1077 (Oros hydromorphone) trial will evaluate the safety and efficacy of the drug in the treatment of chronic low back pain. Enrollment is slated to begin later this year.
Puricase Phase III Studies Complete
Posted 10/17/07
Ttwo Phase III clinical trials for pegloticase (Puricase) have been completed in patients with treatment-failure gout, an orphan indication. Pegloticase is a pegylated recombinant mammalian urate oxidase being developed to control hyperuricemia in patients for whom conventional therapy is contraindicated or has been ineffective. The two studies included more than 200 patients in whom pegloticase or placebo was administered by a two-hour intravenous infusion. Each study had three arms: placebo, Puricase 8 mg administered every two weeks or Puricase 8 mg administered every four weeks.
Positive Results From ALO-01 Study
Posted 10/17/07
Results from a Phase II study of ALO-01, an extended-release morphine sulfate plus sequestered naltrexone, were released. ALO-01 showed similar effectiveness to Kadian (morphine sulfate extended-release) in osteoarthritis patients with moderate to severe chronic pain. The sequestered naltrexone did not interfere with patients’ pain relief. ALO-01 combines an extended-release opioid with sequestered naltrexone, an opioid antagonist.
