The University of Maryland School of Pharmacy has begun a unique study of the "switchability" of federally approved generic and brand anti-epileptic drugs, funded by a $1.1 million, 2-year grant from the U.S. Food and Drug Administration.

Principle investigator James Polli, PhD, a professor with the school, says the study is designed to address patient and health care provider concerns about whether FDA-approved generic and brand anti-epileptic drugs, specifically carbamazepine and levetiracetam, can continue to be considered equally safe and effective.

Polli's team will analyze and assess tablets of the two drug versions for pharmaceutical quality, and "switchability-related" side effects or seizures in epileptic patients who have reported problems. Patients will participate in clinical trials from the University of Maryland Medical Center and the Veterans Administration Hospital in Baltimore.

The research team will "fully characterize" the drug products in terms of potency, impurity, in vitro dissolution, and other quality attributes. "The outcome of this study can help address the public concerns regarding the quality of generic antiepileptic drugs (AEDs) and improve regulatory review practices of generic AEDs when necessary," says Polli.

Polli says, few such comprehensive comparative studies have been published. "This research is a good start on such comparisons because several epilepsy organizations do express concerns about the interchangeability of AEDs and claim that there is an increase in seizure frequency after a generic substitution for many AEDs".

In 2007, the American Academy of Neurology issued a position statement opposing generic substitution of anticonvulsant drugs for the treatment of epilepsy without the attending physician's approval.

The FDA requires tests and procedures to assure that an approved generic drug provides the same therapeutic effect and safety profile as the corresponding brand product. An FDA-approved generic drug is then considered interchangeable with the brand product under all approved indications and conditions of use, and no additional testing of patients is necessary when a generic substitution occurs. This interchangeability also applies to a generic to generic switch when both are deemed equivalent to a brand product.

The principle investigators are Polli, Tricia Ting, MD (co-principal investigator at U of Maryland), and Elizabeth Barry, MD (co-principle investigator at Baltimore VA Medical Center). Other faculty researchers are Allan Krumholz, MD, Maureen Kane PhD, Stephen Hoag, PhD, and Thomas Dowling, PhD.

Source: University of Maryland Baltimore

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