Boehringer Ingeleim’s Viramune XR receives FDA approval

RIDGEFIELD, Conn.—Boehringer Ingelheim announced today thattheir HIV-1 nevirapine drug Viramune XR has received approval from the U.S.Food and Drug Administration (FDA) for use in combination with otherantiretroviral agents in treating HIV-1 in adults. Viramune XR is anextended-release tablet (400 mg) taken once daily.

"With the approval of once-daily Viramune XR, patients inthe U.S. now have the benefit of a new HIV treatment option for use incombination with their other HIV medications," says Dr. Joseph Gathe Jr., clinical instructor of the Department of Internal Medicine, Baylor College ofMedicine, and lead investigator of the VERxVE clinical trial.

Viramune RX's approval was based on data from the Phase IIIVERxVE clinical trial, which effectively demonstrated that Viramune RX couldachieve a virologic response that was not inferior to that of Viramune,Boehringer's 200 mg, twice-daily immediate-release drug, through 48 weeks. Thedrugs were tested in combination with Truvada in treatment-naïve HIV-1 infectedadult patients, and results showed that Viramune RX's safety and tolerabilityprofile was comparable to that of Viramune.

"Boehringer Ingelheim is committed to improving HIV therapyby providing physicians and patients with innovative antiretroviral medicineslike Viramune XR," says Dr. Peter Piliero, executive director of MedicalAffairs at Boehringer Ingelheim Pharmaceuticals, Inc. "For patients switchingfrom Viramune, the new formulation of nevirapine provides a dosing option thatmay decrease pill burden and dosing frequency."

An additional, supporting study, TRANxITION, was alsoundertaken. TRANxITION was a Phase III study that demonstrated that HIV-1infected Viramune-experienced adult patients could safely switch to ViramuneXR, which Gathe says offers physicians the opportunity to "switch their current Viramune patients to a once-daily product with demonstrated comparable safetyand efficacy."

The VERxVE study demonstrated that in treatment-naïvepatients, Viramune XR had a comparable safety and efficacy profile as Viramune.The most common side effect of Viramune XR is rash, and the most seriousadverse reactions include hepatitis, hepatic failure, Stevens-Johnson syndrome,toxic epidermal necrolysis and hypersensitivity reactions.