Clinical trial finds J&J’s tapentadol ER reduces lower back pain in patients
RARITAN, N.J. An investigational drug made by Johnson & Johnson for treating pain showed significant reduction in pain intensity compared with placebo in patients with moderate to severe lower back pain, according to results of a late-stage clinical trial announced Monday.
Results of a phase-3 trial, published online in the journal Expert Opinion on Pharmacotherapy, indicated that tepentadol extended-release tablets reduced pain by at least 30% in patients compared with placebo. The drug uses the same active ingredient as J&J’s Nucynta, an immediate-release formulation.
“The study provides important data regarding the safety and efficacy of tapentadol ER,” said Bruce Moskovitz, therapeutic area leader for pain at Ortho-McNeil-Janssen Scientific Affairs, a division of J&J. “We are pleased that results show tapentadol ER may effectively relieve moderate to severe chronic low back pain while demonstrating a favorable tolerability profile.”
GNC to sell branded retail, food-service equipment
LOS ANGELES General Nutrition Centers has inked a deal to sell its retail and food-service equipment with the help of IMG Licensing and The Legacy Cos.
IMG’s licensing agreement for GNC with The Legacy Cos. will give way to the creation of GNC-branded products, such as blenders and juicers, which will be distributed in the company’s stores. The products will retail from $150 to $400, IMG said.
The agreement will run through 2015.
“GNC has set the standard as an industry leader in the nutritional supplement business and is truly dedicated to helping its customers improve health and quality of life. Teaming up with The Legacy Cos. to expand its brand and create this new and exciting product line will continue to solidify GNC’s brand and its commitment to providing exceptional products and services to consumers,” said Tim Rothwell, IMG EVP and co-managing director of worldwide licensing.
Added GNC EVP Tom Dowd, “GNC is very excited to partner with a high-quality manufacturer that can produce a variety of products that complement the healthy lifestyle of our customers.”
Perrigo seeks approval for generic Zegerid OTC, Schering-Plough files suit
ALLEGAN, Mich. Perrigo has filed for regulatory approval of a generic version of an over-the-counter medication for frequent heartburn, prompting a lawsuit from the branded version’s manufacturer.
The company announced Friday that it had filed for approval for omeprazole and sodium bicarbonate in the 20 mg/1,100 mg strength. The medication is a generic version of Zegerid OTC, made by Schering-Plough HealthCare, a subsidiary of Merck.
Schering-Plough filed a lawsuit Monday alleging patent infringement in the U.S. District Court for the District of New Jersey to prevent Perrigo’s commercialization of the product.
Zegerid had sales of around $60 million during the 12-month period ended in the “most recent month,” according to SymphonyIRI Group.