FDA grants NDA to Tishcon dietary supplement

Trials to begin for CoQ10 in treating rare mitochondrial disorders

Every manufacturer of dietary supplements knows that prescription drug profits only come from selling prescription drugs carrying U.S. Food and Drug Administration-approved indications, and advertised based on approved health claims. With few exceptions supplements have not been shown to benefit individuals with severe or chronic diseases. Therefore it's usually not worth the risk to try to obtain full FDA approval for supplements with marginal efficacy.

Once in a while, however, a company is willing to take a risk on an Investigational New Drug application. Tishcon Corp. (Westbury, NY) announced on October 19 that FDA has accepted its company's Investigational New Drug (IND) application for UbiQGel, a supplement whose active ingredient is coenzyme Q10. Tishcon expects that Phase I pharmacokinetic/bioavailability studies will begin shortly at the Cincinnati Children's Hospital under the direction of Michael Miles. Protocols for clinical studies of UbiQGel in patients with mitochondrial cytopathy are under development and expected to begin early next year.

Tishcon president Raj Chopra described FDA's decsion as "a rare breakthrough for a dietary supplement."

Mitochondrial cytopathies encompass a group of debilitating diseases, which are in most cases caused by an inherited defect and/or dysfunction in the mitochondria. MELAS syndrome, Kearns-Sayre syndrome, and MERRF syndrome are some of the more common mitochondrial diseases. Coenzyme Q10 is an essential co-factor in the mitochondrial energy production cycle. It is synthesized in the body and is also obtained through food.

For more information, contact Raj Chopra, president of Tishcon Corp., at 516-333-3050.

Edited by Angelo DePalma
Managing Editor, Drug Discovery Online and Pharmaceutical Online
Email: adepalma@vertical.net