In an unusual move that boosts the credibility of the nutritional supplement industry, the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to Tishcon Corp.'s (Westbury, NY) UbiQGel (Coenzyme Q10) treatment for mitochondrial cytopathies (MC).

Under the Orphan Drug Act, the FDA is given the authority to expedite drug approval under unusual circumstances. The agency may also award research grants for conducting clinical studies. Upon successful completion of the clinical trials, the FDA awards developers seven years of marketing exclusivity. These incentives allow companies to invest in the development of drugs aimed at treating rare or "orphan" diseases.

Mitochondrial Cytopathies encompass a group of debilitating diseases, which are in most cases caused by an inherited mitochondrial defect or dysfunction. MELAS syndrome, Kearns-Sayre syndrome, and MERRF syndrome are some of the more common mitochondrial diseases.
According to Raj Chopra, president of Tishcon, clinical trials of UbiQGel in mitochondrial cytopathy patients will begin this fall, and should be completed in approximately two years.

UbiQGel contains coenzyme Q10, a nutritional supplement, as its active component. As an essential cofactor in mitochondrial energy production, coenzyme Q10 is synthesized in the body and is also obtained through food. UbiQGel allegedly is a more bioavailable form of Q10.

COMMENT: Unbiquinone or CoEnzyme Q10 is an important nutrient, and not primarily for the reasons mentioned above. Two of its primary uses are for those who are taking high cholesterol pills (particularly, the statin drugs). These pills inhibit the production of CoQ10 by the liver and will cause serious complications unless one supplements CoQ10 back in. The other major use of CoQ10 would be in the case of congestive heart failure, where it is particularly effective. It is encouraging though to see that the FDA is approving some of these nutritonal therapies.

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