J&J: Extended-release tapentadol may reduce pain associated with diabetes complication
RARITAN, N.J. — A drug made by Johnson & Johnson may be effective in reducing pain in patients with a complication of diabetes, according to a late-stage clinical study.
The phase-3 study, published in the January issue of the journal Current Medical Research and Opinion, found that extended-release tapentadol was more effective than placebo in relieving moderate to severe chronic pain in patients with diabetic peripheral neuropathy. J&J markets an immediate-release formulation of the drug under the brand name Nucynta, which the Food and Drug Administration approved in November 2008.
“What’s encouraging is that at the beginning of this study, the average pain rating across the entire group of patients was severe, but after three weeks on tapentadol ER, the average pain score dropped substantially to a range considered to be mild pain,” therapeutic leader for pain at J&J subsidiary Ortho-McNeil-Janssen Scientific Affairs Bruce Moskovitz said. “After double-blind randomization, the group of patients that stayed on tapentadol ER maintained its pain reduction, while the group that switched to placebo experienced a significant increase in its average pain score.”
Pfizer chief medical officer honored by HBA
NEW YORK — The chief medical officer at one of the largest drug makers in the world has been named "woman of the year" by the Healthcare Businesswomen’s Association.
Freda Lewis-Hall, Pfizer’s chief medical officer, will be honored at the HBA’s 22nd annual "Woman of the Year" luncheon in May.
Lewis-Hall’s 30-year career in healthcare leadership includes roles in direct patient care, academics, media, government, pharmaceuticals and biotechnology.
HBA president Deborah Coogan Seltzer said that Lewis-Hall "sets the tone" for those in the industry for her "long-standing commitment to the social responsibilities of healthcare leadership — especially in making sure that people have the education and understanding to make the best healthcare decisions."
Mylan’s generic Sular gets FDA OK
PITTSBURGH — The Food and Drug Administration has approved a generic hypertension treatment made by Mylan.
Mylan announced the approval Friday of nisoldipine extended-release tablets in the 8.5-mg, 17-mg, 25.5-mg and 34-mg strengths. The drug is a generic version of Shionogi Pharma’s Sular, which had sales of about $103 million during the 12-month period ended in September 2010, according to IMS Health.
Mylan was the first company to file a regulatory approval application for the drug and is thus entitled to 180 days in which to compete directly with the branded version under the provisions of the Hatch-Waxman Act of 1984, the law that created a regulatory approval pathway for generic pharmaceutical drugs.