Viramune® (nevirapine) prolonged-release once-daily formulation receives approval in the EU
Posted: 21 September 2011 | | No comments yet
Once-daily Viramune® (nevirapine) prolonged-release has received approval…
Boehringer Ingelheim announced today that once-daily Viramune® (nevirapine) prolonged-release has received approval for use in the EU. 1 The new, prolonged-release tablet is indicated in combination with other antiretroviral medications for the treatment of HIV-1 infection.
EU approval for the use of one 400 mg tablet once daily for adults and adolescents – and for 50 mg and 100 mg strengths for once-daily treatment of children – is based on results from clinical trials confirming the significant therapeutic benefits of nevirapine when administered in a convenient once-a-day formulation. 2,3
The Viramune® XR™ single 400 mg tablet once daily was approved in the USA by the Food and Drug Administration (FDA) earlier this year.
In clinical trials, the antiviral efficacy of Viramune® prolonged-release tablets was shown to be non-inferior to the older, twice-daily immediate-release (IR) 200mg tablet, 2,3 with a safety and tolerability profile comparable to nevirapine IR.
Dr. Keikawus Arastéh, Director of Internal Medicine at Vivantes Auguste-Viktoria-Klinikum, Berlin, Germany, commented: “Nevirapine prolonged-release provides physicians and patients with a simplified, once-daily treatment while maintaining the high level of efficacy, comparable tolerability and favourable lipid profile already associated with the nevirapine immediate-release formulation.”
He added: “Switching therapies and a low pill burden can improve treatment adherence, which is often key to treatment success.”
Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim Headquarters, stated: “Data show that Viramune® prolonged-release, combines the trusted clinical benefits of nevirapine with the convenience of a single tablet, once daily dose. Nevirapine prolonged-release allows an easy switch for patients currently taking nevirapine twice-daily.”
“Viramune® prolonged-release tablets give patients a simplified treatment option without compromising on clinical efficacy and fits in with today’s prescribing trends,” he added.
