Ovos Natural Health, the nutraceutical arm of the drug firm Bellus Health set up as a new subsidiary last year, has filed a citizen petition with FDA requesting New Dietary Ingredient status for its homotaurine ingredient.
Homotaurine is an amino acid found in certain species of seaweed. Clinical trials on the patented ingredient, which is a ‘nature identical’ compound, have found that it can help support brain health and preserve memory, prompting the company to wish to market it as a supplement ingredient for brain health and memory support.
The firm’s branded homotaurine product, Vivimind, has this month received the green light for sale as a food supplement in Italy from the Italian Ministry of Health.
New supplement ingredients in Europe (excepting vitamins and minerals) must be approved at a national level, but entry into one market often clears the road for easier entry in other European markets.
Alternative path to market
Ovos is also pursuing marketing approval in the US via the citizen petition submitted last month by food attorney Marc Ullman.
The company is pursuing the nutraceutical arena for its product as an “alternative pathway to market”, after it failed to meet drug efficacy standards in a Phase III trial, which tested the ingredient in 1,052 Alzheimer’s disease patients above the age of 50.
“While the results of the that trial indicated that homotaurine was safe, issues relating to the ability to achieve statistically significant results acceptable to FDA for the primary efficacy study endpoints led the company to conclude that it was no longer economically feasible to complete drug approval process,” states the petition.
Consequently, Bellus withdrew its application for approval of homotaurine as an Investigational New Drug Application (NDI) in May last year.
So as not to lose the investment made in research under the IND, the firm created its subsidiary Ovos “specifically for the purposes of commercializing homotaurine as a dietary supplement”.
The Federal Food Drug and Cosmetic Act (FDCA) seeks to protect the pharmaceutical market by stating that a substance cannot be marketed as a dietary supplement if it has been authorized for investigation as a new drug “unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this Act”.
As such, the petition is requesting that FDA establish a regulation pursuant to FDCA to allow for the legal use of Ovos’ homotaurine as a dietary ingredient in dietary supplements.
“Ovos believes that the introduction of homotaurine as an ingredient for use in dietary supplements has the potential to result in significant benefit to consumers by providing a unique new entrant into the cognitive support dietary supplement category that is backed by a significant body of scientific evidence,” states the petition.
The firm said its trials on the ingredient have demonstrated that after 18 months it preserved hippocampus volume by 68 percent compared to placebo and improved cognitive performance by 33 percent compared to placebo after one year.
These findings, it said, support the use of a number of structure/function claims, including:
- Protects the brain structure associated with memory and learning
- Preserves memory
- Sustains brain cell health
- Maintains verbal skills and comprehension ability
- Supports planning and execution skills
Ullman told NutraIngredients-USA.com that there has been no response to the petition as yet. “We are hoping to have the process completed by the end of the first quarter of 2010,” he said.
To view the petition, click here.