New Drugs Arriving at Pharmacies

-2 -
Rescriptor, a non-nucleoside reverse transcriptase inhibitor (NNRTI), received marketing
clearance from the U.S. Food and Drug Administration under accelerated approval regulations on
April 4. Rescriptor is the second NNRTI which attacks the virus at a different point than the other
available AIDS medications. The drug is indicated for use in combination with appropriate
AIDS drugs to treat patients with HIV infection when treatment is warranted. This indication is based on
surrogate marker changes in clinical studies. In a completed trial comparing Rescriptor plus didanosine
with didanosine monotherapy, clinical benefit was not demonstrated for Rescriptor based on survival or
incidence of AIDS-defining clinical events.
In clinical studies, the main side effect attributable to Rescriptor was a skin rash, which was seen
in 18 percent of patients given the recommended dose. In most cases, the rash disappeared within 3-14
days without dosage reduction or interruption of treatment. In two pivotal trials, 4.3 percent of patients
treated with the recommended dose of Rescriptor discontinued treatment due to skin rash.
The recommended dosage for Rescriptor is 400 mg, taken three times daily. The drug is
dispersible in water and can be taken with or without food. Rescriptor sells at a Wholesale Acquisition
Cost of $6.16 per day or $2,250 annually.
Physicians or patients who have clinical questions about Rescriptor can call P&U's hotline
number at 1-800-432-4702. The company has established a reimbursement assistance program to
actively help patients and providers find methods of payment for Rescriptor. Interested parties should
call 1-800-711-0807.
Pharmacia & Upjohn is a global, innovation-driven pharmaceutical and health care company.
Pharmacia & Upjohn's products, services and employees demonstrate its commitment to improve
wellness and quality of life for people around the world.

(end)