A potentially dangerous and oft-abused class of painkillers will be required to have REMS risk management programs in place under an FDA edict covering all extended release and long-acting opioid analgesics, a category covering 30 drugs manufactured by 20 companies. The agency said it had decided to require a Risk Evaluation and Mitigation Strategy of the extended-release and long-acting products but not immediate release drugs because “FDA has concluded that there is a disproportionate safety problem associated with these products that must be addressed.” The products include Purdue’s OxyContin, Palladone, Butrans and MS Contin; Pfizer’s Avinza and Embeda; Janssen’s Duragesic and Nucynta ER; and Endo’s Opana ER, among others.
Church & Dwight Co., the maker of Trojan Brand Condoms, is sponsoring a series of HealthGuru.com videos on sexual health topics. The videos, aimed at teens and young adults, follow Healthguru’s Q&A format, allowing users to engage directly with a panel of sexual health experts. “Via our partnership with HealthGuru.com, we’re providing an accessible space for people to receive the information they need to make informed decisions about their sex lives and bring more pleasure into the bedroom,” said Trojan VP marketing Bruce Weiss.
The FDA approved Mumbai-based Lupin Pharmaceuticals’ bid to market a generic version of Lyrica (pregabalin). The Pfizer drug was indicated for neuropathic pain associqted with diabetic peripheral neuropathy, post herpetic neuralgia, adjunctive therapy for adult patients with partial onset seizures and fibromyalgia, and saw sales of around $1.8 million in the US for the year to March 2012.
