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FDA Approves One Tablet/Once Daily Formulation of Sustiva (Efavirenz) for HIV PRINCETON, NJ -- February 4, 2002 -- Bristol-Myers Squibb today announced the approval in the U.S. of a new one-tablet 600 mg formulation of its widely used once-daily anti-human immunodeficiency virus (HIV) drug Sustiva® (efavirenz). Sustiva is a once-daily non-nucleoside reverse transcriptase inhibitor (NNRTI) used in combination treatment for HIV. The new formulation will provide doctors with the option to prescribe one 600 mg Sustiva tablet once daily instead of three 200 mg capsules once-daily (as Sustiva has been used since it was approved in September 1998). The 600 mg tablet is approximately the same size as one Sustiva 200 mg capsule. "The new tablet formulation of Sustiva will help reduce the number of pills patients have to take in their HIV treatment which may help them better adhere to their regimens," said Jeffrey Hatfield, Senior Vice President, Bristol-Myers Squibb Virology. "It is clear that one of the major issues associated with HIV therapy is the frequency and amount of pills patients take." The 600 mg tablet formulation will be available in late February. It will be packaged in bottles of 30 (one-month's supply). Bristol-Myers Squibb will continue to manufacture the 200 mg capsules for those who still wish to take Sustiva as three capsules once daily as part of their combination regimen. "As physicians look to prescribe easier-to-use regimens to treat patients with HIV, the availability of Sustiva as a one-tablet, once-daily component is a welcome addition to the treatment armamentarium," said Brian Boyle, MD, Assistant Professor, Cornell University Medical College, attending physician, New York-Presbyterian Hospital. "As we move towards once-daily treatment regimens with low numbers of pills for our patients, products like Sustiva will be the cornerstone that we build these regimens around." In February 2001, the U.S. Department of Health and Human Services (DHHS) continued, for the second year in a row, to list Sustiva as the only NNRTI "strongly recommended" for use in first-line combination with NRTIs for the treatment of HIV-infected individuals. It is recommended that Sustiva be taken on an empty stomach, preferably at bedtime. Sustiva is generally well tolerated. Many patients have dizziness, trouble sleeping, drowsiness, trouble concentrating, and/or unusual dreams. These feelings tend to go away after taking Sustiva for a few weeks. A small number of patients taking Sustiva have reported severe depression, strange thoughts, or angry behavior. There have been a few reports of suicide but Sustiva has not been established as the cause. One of the most common side effects is rash which is usually mild and goes away in a few weeks. SOURCE: Bristol-Myers Squibb E-mail this page to a friend or colleague! To print, use this version