Excerpts from Press Announcement Of Application to the FDA for 1 Efavirenz Pill Per Day Instead of 3 200 mg Pills
Wilmington, DE April 4, 2001
DuPont Pharmaceuticals Company today announced it has submitted a new drug application to the U.S. Food and Drug Administration (FDA) for both a 600 and 300 mg tablet formulation of its anti-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 patients with the option to take one 600 mg Sustiva tablet once daily instead of the currently approved three 200 mg capsules once daily. The 600 mg tablet is approximately the same size as a Sustiva 200 mg capsule.
Pending FDA approval, DuPont Pharmaceuticals hopes to launch the 600 and 300 mg formulations in early 2002 and will continue to manufacture the 200 mg capsules for those who still wish to take Sustiva as three capsules once-daily.
The new 600 mg single daily tablet has the potential to further improve adherence and therapy success for people living with HIV. Results of a recent adherence survey** indicate that approximately 60 percent of HIV- positive patients find it difficult to adhere to their antiretroviral regimen. Some of the reasons associated with this difficulty include too many pills (67 percent), side effects (61 percent), food restrictions (55 percent) and frequency of having to take the pills (49 percent). The availability of Sustiva as one or two pills per day as part of a combination regimen may help patients cut down the number of pills required per day.
Women should not become pregnant while taking Sustiva because birth defects have been seen in animals given Sustiva. Patients should be cautioned not to operate hazardous machinery or drive if they experience nervous system symptoms.
Sustiva is currently administered as three 200 mg capsules once-daily. Sustiva should not be administered concurrently with Hismanal® (astemizole), Propulsid® (cisapride), Versed® (midazolam), Halcion® (triazolam) or ergot derivatives. Current treatment guidelines recommend against the use of any antiretroviral agent as monotherapy. Therefore, Sustiva must not be used as a single agent to treat HIV or added on as a sole agent to a failing regimen. The choice of new antiretroviral agents to be used in combination with Sustiva should take into consideration the potential for viral cross-resistance. Sustiva therapy should always be initiated in combination with at least one other antiretroviral agent to which the patient has not been previously exposed.