HEALTH

Cirrus targets ear-ringing with Tinnitex

BY Allison Cerra

COLD SPRING HARBOR, N.Y. Cirrus Healthcare Products has expanded its ear care offerings with a new product, slated to hit retail shelves in spring 2011.

Tinnitex is the first and only earplug to help relieve tinnitus, a condition that causes ringing in the ears, the company said. According to the Journal of Clinical Nursing, more than 50 million Americans suffer from tinnitus.

“Tinnitex gives the suffering consumer an option to the inconvenience of ear drops or the excessive amount of pills that consumers are tired of taking. The Tinnitex earplug is easy to apply and comfortable to wear and, at about $10 at retail for six pairs, provides affordable relief,” said Cirrus CEO Drew O’Connell.

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In testimony, NACDS hails federal effort to simplify patient medication information

BY Jim Frederick

ROCKVILLE, Md. Federal efforts to simplify and standardize the information that patients receive with their prescription medications are laudable and should continue, the chain pharmacy lobby told Obama administration health officials Monday.

That message to the Food and Drug Administration came from the National Association of Chain Drug Stores, which has pushed for simpler patient package inserts, and on a more basic level, a single standard for conveying patient medication information. In a presentation to an FDA public hearing, NACDS VP government affairs and pharmacy adviser Kevin Nicholson said his group is “very pleased” that the agency appears to be moving toward a single information document with standardized format and content. He urged federal health officials to “continue to move toward this laudable goal with all reasonable haste.”

Under current FDA rules, Nicholson testified, “Patients receive several different types of information, developed by different sources that may be duplicative, incomplete, or difficult to read or understand.” The agency should work with NACDS, other pharmacy groups, manufacturers and patients themselves, he asserted, to come up with a “one document solution” to the knotty issue of PMI.

“Patients want a useful document, designed and written for them, that recognizes their information needs, that focuses concisely on critical information and that provides them with clear instructions on where to go for further advice and instruction,” Nicholson told the FDA panel. What’s more, he said, “The provision of multiple documents, containing redundant or even conflicting information, creates logistical and financial burdens for pharmacies that compromise effective patient counseling. It would be far more convenient, efficient and ultimately more effective for pharmacists to counsel patients by providing a single document that could easily be understood and facilitate a discussion concerning proper use of medication.”

That said, the NACDS executive noted, “our first recommendation is for FDA approval of all PMI. However, considering that FDA approval may not be feasible, we urge the agency to develop pilot programs to test various modes of ensuring standard content and format, including using simplified and modified PPIs as PMI. Any pilot program should also test different modes of patient access and delivery to the patient at the pharmacy, at the point of prescribing and via the Internet and/or electronic health records,” Nicholson concluded. “The key to success for PMI will be for continued collaboration among the agency, manufacturers, pharmacies, prescribers and consumer groups.”

In mid-2008, NACDS and seven other pharmacy and consumer organizations submitted a citizen petition to urge the FDA to move to “a concise, plain-language document for patients that would consolidate and replace the multiple written communications pharmacies currently are required to distribute to patients.” Adopting a standard, easier-to-understand medication information format, Nicholson told the agency, would help boost patient adherence, improve health outcomes and cut needless healthcare expenditures.

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Clinical trial finds J&J’s tapentadol ER reduces lower back pain in patients

BY Alaric DeArment

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.”

 

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