FDA OKs Pregabalin Extended-release Once-Daily Tablets for Neuropathic Pain
The tablets did not get approval for managing fibromyalgia, however, according to a press release from Pfizer.
Officials with Pfizer have announced that the FDA has approved pregabalin (Lyrica) extended-release tablets CV as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy (pDPN) and the management of postherpetic neuralgia (PHN). The tablets did not get approval for managing fibromyalgia, however, according to a press release from Pfizer.
The efficacy and safety of the tablets was established in a randomized placebo-controlled clinical trial conducted in 801 patients with PHN who entered single-blind treatment. As both pDPN and PHN are peripheral neuropathic pain conditions, the PHN data was supportive of both the pDPN and PHN indications.
The randomized trial included a 6-week single-blind, dose optimization phase followed by a 13-week double-blind phase. In the PHN study, 73.6% of patients in the LYRICA CR group achieved at least a 50% improvement in pain intensity compared with 54.6% in the placebo group.
The most common adverse reactions reported with LYRICA CR were dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth and weight gain.
U.S. FDA APPROVES LYRICA® CR (PREGABALIN) EXTENDED-RELEASE TABLETS CV [news release]. Pfizer website. http://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_lyrica_cr_pregabalin_extended_release_tablets_cv. Accessed October 12, 2017.