From Bench to Bedside

FDA Declines to Approve Remoxy, an Extended-release Oral Formulation of Oxycodone

The FDA denied approval for the drug, being co-developed by Pfizer and Pain Therapeutics, Inc, based on concerns over “inconsistent release performance” during testing, among other problems cites in the complete response letter it sent to the companies (http://hcp.lv/ jY9rPh). An article published on website of the Austin American-Statesman (Pain Therapeutics is based in Austin, TX) noted that it is not clear yet whether the inconsistencies flagged by the FDA were the result of problems with the manufacturing process or with the tests themselves (http://hcp.lv/jTPmZG). It is not known at this point how long this latest setback will delay approval of Remoxy.

Short-acting Oxecta Approved for the Management of Acute and Chronic Moderate to Severe Pain, but Company Must Perform Additional Research to Demonstrate the Abuse-deterrent Potential

The FDA in June approved the drug Oxecta, a new formulation of oxycodone hydrochloride, for the management of acute and chronic moderate to severe pain (http:// hcp.lv/jzUFpk). Made by Pfizer using Acura Pharmaceuticals’ “Aversion Technology” (http://hcp.lv/lOq9DX) that provides “abuse deterrent features and benefits for orally administered pharmaceutical drug products,” Oxecta is an immediate-release oxycodone formulation. Opioid-naïve patients should be started on this medication at 5 to 15 mg every four to six hours as needed for pain (http:// hcp.lv/madbXI). Oxecta is contraindicated in patients with respiratory depression, paralytic ileus, and acute or severe bronchial asthma or hypercarbia. It should be used with caution in patients with head injuries or other intracranial lesions, severe renal or hepatic impairment, Addison’s disease, hypothyroidism, prostatic hypertrophy, urethral stricture, or mental impairments.

St. Jude Medical Inc Releases Favorable Study Results for Its Peripheral Occipital Nerve Stimulator for Chronic Migraine

In the study, 157 patients who suffered from an average of 26 headache days per month were randomized to 12 weeks of treatment with either placebo or the Genesis neurostimulator. Patients were followed for one year. Patients in the active treatment group reported a 28% decrease in their number of headache days (seven less days a month) compared to the placebo group (http://hcp.lv/l62Csx). Patients also reported significant improvements in their pain as expressed by scores on the Zung Pain and Disability Index and MIDAS scales.