Syntex has submitted a New Drug Application to the US Food and Drug Administration for its oral formulation of the antiviral ganciclovir. The company is seeking approval to market the drug for the maintenance treatment of cytomegalovirus retinitis in people with compromised immune systems, including those with AIDS. The condition affects approximately 15% of patients with full-blown AIDS.
Syntex has marketed an intravenous form of this antiviral for the management of CMV retinitis under the brand name Cytovene since 1989 in the USA and also, under various other names, since 1988 outside the USA. Cytovene is marketed in over 50 countries worldwide.
Oral Versus IV Form Syntex' NDA was based on the results of three controlled clinical trials which assessed the efficacy of the oral version in maintaining patients with CMV retinitis who had previously been stabilized with the intravenous formulation. The studies were comparative in nature; after stabilization patients were randomized to receive either oral ganciclovir (3,000mg/ day) or the intravenous form of the drug as a maintenance therapy.
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