First Approval For Delavirdine NNRTI

Pharmacia & Upjohn's Rescriptor (delavirdine) has been approved in itsfirst market, the USA, and becomes the second non-nucleoside reverse transcriptase inhibitor to be cleared for the treatment of HIV-1 infection after Boehringer Ingelheim's Viramune (nevirapine). Rescriptor is indicated for use in combination with other anti-HIV medications.

The recommended dosage for Rescriptor is 400mg, taken three times a day. The drug comes in 100mg tablets, which can be dispersed in water to make consumption easier. It can be taken with or without food. P&U plans to launch the drug "within three to four weeks." The average wholesale price in the USA will be $6.16 a day, or $2,250 a year, at the recommended dose. Nevirapine is priced at around $6.88 a day, and both NNRTIs cost much less than the four available protease inhibitors, which come in at between $12 and $18 a day. P&U will offer a minimum rebate of 15.1% of the average manufacturer's price of the drug to AIDS Drug Assistance Programs unable to purchase products at government-discounted rates.

Approval Despite Limited Data Rescriptor has been studied in combination with several nucleoside RTIs in more than 2,400 patients, in a series of clinical trials starting in April 1994. In surrogate marker trials, the drug, in combination with zidovudine (Glaxo Wellcome's Retrovir), achieved significantly greater reductions in plasma viremia compared to zidovudine alone.