(Princeton, NJ, January 31, 2000) -- Bristol-Myers Squibb announced today that it has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for a new formulation of VIDEX (R), also known as ddI. The new capsules contain enteric coated VIDEX beadlets designed to protect the essential medicine in VIDEX from degrading until it has passed through the stomach, thus eliminating the need for a buffer. If approved, VIDEX capsules will further reduce pill burden from two tablets to a single capsule dosed once a day.
"Guided by our mission to extend and enhance human life, Bristol-Myers Squibb has been a leader in the search to find effective therapies for HIV/AIDS for more than a decade," said Rick Winningham, President, Bristol-Myers Squibb Oncology/Immunology. "We are continuously conducting research to improve the tolerability, potency and convenience of our therapies. The submission of the new enteric coated formulation of VIDEX is an important milestone in our quest to ease the management of complex regimens for patients."
Today's antiretroviral drug regimens can be complicated and often result in unpleasant or serious side effects. As many as four drugs are often prescribed and patients are burdened with taking up to 20 pills, several times a day, making it especially difficult to remain on prescribed therapy. When patients do not adhere to prescribed treatment regimens, the efficacy of treatment is reduced.
VIDEX (didanosine) received marketing clearance in the U.S. in 1991 for the treatment of HIV/AIDS and is marketed by Bristol-Myers Squibb in over 70 countries around the world. In October 1999, the FDA approved VIDEX tablets for once-a-day dosing; concurrently, BMS launched a 200 mg tablet which simplifies dosing to two tablets once a day. Patients must take at least two of the appropriate strength tablets to provide adequate buffer to prevent gastric acid degradation of VIDEX.