Clinical Trial Reports
ROXRO announces FDA accepts for review NDA For ROX-888 for the management of acute moderate to severe pain
February 7, 2009 [Source: Roxro Pharma]
ROXRO announced that the U.S. Food and Drug Administration has accepted for review the New Drug Application for its lead investigational prescription drug candidate, ROX-888, for the management of acute moderate to severe pain. ROX-888 is an intranasal formulation of ketorolac, a non-steroidal anti-inflammatory drug (NSAID), designed to provide ambulatory patients with a convenient, potent, and fast-acting option for acute pain relief, without the risk of addiction or the other negative effects of narcotics. Story
BioElectronics announces results of menstrual pain pilot clinical study
February 05. 2009 [Source: BioElectronics Corp]
BioElectronics Corp, the maker of inexpensive, disposable drug-free anti-inflammatory devices, today announced results of a new pilot clinical study on use of the company's Allay(TM) product for the treatment of menstrual pain. Story
Cymbalta(R) significantly reduced osteoarthritis knee pain in new study
January 30, 2009 [Source: Eli Lilly and Co.]
In a new study, Cymbalta (duloxetine HCl) 60-120 mg, taken once daily, reduced pain severity significantly, compared with placebo, in patients with osteoarthritis pain of the knee. Data from the 13-week randomized, double-blind, placebo-controlled clinical trial(1) were presented at the annual meeting of the American Academy of Pain Medicine (AAPM) in Honolulu, Hawaii. Story
King Pharmaceuticals, Inc. reports results from its Phase III 12-month open-label safety and efficacy study evaluating EMBEDA(TM) (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules.
January 30, 2009 [Source: King Pharmaceuticals]
King Pharmaceuticals, Inc. today reported results from its Phase III 12-month open-label safety and efficacy study evaluating EMBEDA™ (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules. The results showed that EMBEDA™ provided continued pain relief for up to 12 months in opioid-tolerant patients with chronic, moderate to severe, non-malignant pain. Findings also showed that EMBEDA™ was safe and well-tolerated for long-term chronic pain therapy. Story
EpiCept's Phase IIb post-herpetic neuralgia trial meets endpoint
January 29, 2009 [Source: EpiCept]
EpiCept, a specialty pharmaceutical company, has announced positive results from its Phase IIb ran-domized, double-blind, placebo-controlled non-inferiority trial of its prescription topical analgesic EpiCept NP-1 Cream in post-herpetic neuralgia. The trial met its primary endpoints and demonstrated a favorable safety profile compared with gabapentin. Story
Cannasat Therapeutics and IntelGenx Corp. reach key milestone for CAT 310
January 28, 2009 [Source: Cannasat Therapeutics Inc & IntelGenx Corp ]
Health Canada has approved Cannasat's clinical trial application for a Phase 1(b) clinical study with its lead product, CAT 310. Cannasat received a "No Objection Letter" from Health Canada to conduct this clinical study for this product that is designed to help manage neuropathic pain and other disorders Story
Nuvo Research announces successful completion of all Pennsaid(R) studies; company expects to file Pennsaid FDA resubmission within 60 days-
January 28, 2009 [Source: Nuvo Research Inc]
Nuvo Research Inc. has announced that it has successfully completed all of the studies that will support the Company's resubmission of its Pennsaid application to the United States Food and Drug Administration (FDA). Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID), is currently marketed in Canada and several European countries to treat the pain and symptoms associated with osteoarthritis. Story
Map Pharmaceuticals completes enrollment in Phase III migraine trial
January 27, 2009 [Source: MAP Pharmaceuticals, Inc]
MAP Pharmaceuticals, Inc. today announced that it has completed patient enrollment in the efficacy portion of its initial Phase 3 clinical trial evaluating MAP0004. The Phase 3 multi-center, randomized, double-blind, placebo-controlled trial in approximately 850 migraine sufferers is evaluating the safety and efficacy of MAP0004 as a potential acute treatment for migraine. The primary efficacy endpoints are pain relief and freedom from nausea, photophobia and phonophobia as measured at two hours after dosing. Story
Alexza Pharmaceuticals, a specialty pharmaceutical company, has initiated a Phase IIb clinical trial with AZ-104 in patients with migraine headaches
January 21, 2009 [Source: Alexza Pharmaceuticals]
The AZ-104 Phase IIb clinical trial is an outpatient, multi-center, randomized, double-blind, sin-gle-dose, placebo-controlled study in approximately 360 patients who have migraines, with or without aura. Approximately three doses will be evaluated in the clinical trial, placebo and two doses of AZ-104 (1.25 and 2.5mg) Story
Forest and Cypress announce FDA approval of Savella(TM) for the management of fibromyalgia
January 14, 2009 [Source: Forest Laboratories]
Forest Laboratories, Inc. and Cypress Bioscience, Inc. today announced that Savella(TM) (milnacipran HCl), a selective serotonin and norepinephrine dual reuptake inhibitor, was approved by the U.S. Food and Drug Administration (FDA) for the management of fibromyalgia. Story
Jazz Pharmaceuticals, Inc. completes enrollment in second of two Phase III clinical trials of sodium oxybate to treat fibromyalgia
January 13, 2009
Jazz Pharmaceuticals, Inc. announced completion of enrollment in the second of two Phase III pivotal clinical trials of JZP-6 (sodium oxybate) for the treatment of fibromyalgia. The JZP-6 Phase III clinical trial program includes two randomized, double blind, placebo-controlled studies. Story
Repros Therapeutics Inc. announces that Proellex significantly reduced pain in a U.S. Phase 2 clinical trial in women with moderate to severe endometriosis
Repros Therapeutics Inc. released positive results of its recently completed U.S. Phase 2 Proellex endometriosis trial. Proellex is an oral progesterone receptor modulator. The key findings from this double-blind study were: statistically significant reductions in endometriosis symptoms and
all three patient reported outcomes: dysmenorrhea (painful menses), deep dyspareunia (painful intercourse) and non-menstrual pelvic pain
Story
Acura and King Pharmaceuticals file NDA for pains drug
January 5, 2009 [Source: Acura Pharmaceuticals Inc]
The FDA is expected to determine whether to accept the new drug application (NDA) for filing and consider the priority review request within 60 days. If approved, Acura and King believe Acurox will be the first FDA approved immediate release opioid analgesic designed to deter swallowing excess quantities of tablets and other common methods of misuse and abuse Story
|
