Gilead Sciences reported last week that it has settled on a formulation for a therapy that combines Johnson & Johnson’s new TMC278 (rilpivirine hydrochloride) and its own drug Truvada (emtricitabine/tenofovir) into a single pill.

In a press release, Gilead said it planned to file a New Drug Application (NDA) for the combined therapy once TMC278’s is approved for sale by the Food and Drug Administration (FDA).

Johnson & Johnson, which owns Tibotec Pharmaceuticals, the maker of TMC278, announced recently that it expects to file an NDA for the drug in the third quarter of this year.

Gilead said in its press release that its study had successfully demonstrated that the combination drug is as effective at delivering medication into the bloodstream as the two drugs taken separately.

This step is necessary for the combination drug to be approved by the FDA.

Tibotec and Gilead first agreed to develop and market a once-daily fixed-dose therapy in 2009.

TMC278, a non-nucleoside reverse transcriptase inhibitor, is an anti-HIV drug that prevents the virus from replicating itself. The drug is currently being evaluated as a treatment for HIV-positive patients who have not undergone previous therapy.

Typically, the sponsor of a new drug files an NDA once it is confident that data shows that the drug is safe and effective enough to meet the FDA’s requirements for marketing approval.  Once the application is approved, then the company may begin to market the drug in the United States.

Currently, the single-tablet fixed-dose combination of Truvada and TMC278 is still investigational and lacks definite data about its safety and effectiveness.

If approved, the proposed Truvada/TMC278 complete antiretroviral therapy in a single pill would become the second of its kind; Atripla (efavirenz/emtricitabine/tenofovir), a combination of three medications, is the first.

Gilead’s “Quad” regimen (elvitegravir/cobicistat/emtricitabine/tenofovir), a four-drug combination pill, recently began Phase 3 clinical trials (see related Beacon news).

For more information, please see coverage on The Medical News, as well the original press release at Gilead Sciences.