Medical food marketer taken to task over IND filings on studies

19-Apr-2017 - Last updated on 20-Apr-2017 at 15:14 GMT

Targeted Medical Pharma, a company marketing medical foods for pain management, has been hit with an FDA warning letter that illustrates the complexities of this product category and the studies done to support the products.

Targeted Medical Pharma markets three amino acid-based products it positions as medical foods. The company claims the products address certain amino acid deficiencies that arise as a result of chronic pain conditions, deficiencies which affect the production of neurotransmitters. The deficiency in amino acid levels and the products’ ability to address this qualifies them as medical foods, the company has maintained.

Products meant for pain management

The company markets three products: Theramine and Trepadone for pain management, and Percura for peripheral neuropathy. All three are said to be meant to deal with the “dietary management of the altered metabolic processes associated with pain syndromes.”

Targeted Medical Pharma’s technology is based on a patented formulation that the company says allows reduced concentrations of amino acids and other ingredients in the milligram range to stimulate the production of neurotransmitters to treat the nutritional deficiencies associated with certain diseases and conditions.

“All of our products are based on this patented technology,” said marketing manager Marcus Charuvastra. A line of planned dietary supplements has been shelved. The company entered into an agreement to market the products in China early last year.

In the warning letter, which was heavily redacted, FDA disagreed with the company that pain syndromes qualify as conditions for which a medical food can be formulated. “There are, however, no distinctive nutritional requirements for individuals with [pain syndromes],” the agency wrote.

Hemming in medical foods

This objection is similar to those the agency has raised in other cases where companies have sought to position their products as medical foods. The agency has taken a very restrictive view of what conditions qualify for a medical food formulation. Diabetes, for example, has been exempted from a medical food definition. The category was originally created to enable companies to cost effectively market products to address certain inborn errors of metabolism, such as phenylketonuria, in which the amino acid phenylalanine builds up in the body to toxic levels. Individuals suffering with this condition must eat a special diet to avoid taking in too much of this amino acid. A specially formulated phenylalanine-free medical food supplement allows such individuals to get adequate protein in their diet. The agency seems to be attempting to hem the category back into these kinds of tightly-defined, niche applications.

In the warning letter, FDA takes the company to task for not following proper procedure in filing an Investigational New Drug (IND) application on the studies it conducted on its product. The company’s interim CEO, Kim Giffoni, noted in a letter sent to FDA yesterday that the studies in question were conducted years ago and that the company had filed for an IND at that time, and that FDA has misplaced the records. FDA countered that it had no records of the filing and that Targeted Medical Pharma was unable to provide sufficient documentation that such a filing was made.

The company stridently disagreed, and issued this statement attributed to Dr. David Silver, chief medical officer: “The Company has records confirming the submission of the studies with the IRB and submission of the INDs to FDA. FDA was unable to find records of the IND filings. We believe the Company fulfilled the legal and ethical requirements for conduction both studies. The Company has concluded that all products currently marketed as medical foods meet the regulatory standards defined in the Orphan Drug Act.”

The end point is the issue

Attorney Ivan Wasserman, a partner in the firm Amin Talati Upadhye, said doing research into a product that might qualify for a medical food will usually tend to straddle the disease-end point line in which an IND filing might be called for.

“It’s really about the claims you intend to make on your product,” Wasserman told NutraIngredinets-USA. “If you are studying a product that to you looks like a supplement, or a cosmetic, or a food, but the end point of your trial is a disease end poilnt, then you need to have an IND.”