Posts tagged ‘central nervous system’

FDA Advisory Committee – LAMICTAL XR



On March 10, 2011 the FDA will ask the Peripheral and Central Nervous System Drugs Advisory Committee to vote on the use of GlaxoSmithKline LAMICTAL-XR as monotherapy for partial seizures.  Listed on the undercard of the main event, is a discussion and series of questions that the FDA wants the Committee to address related to the use of historical controls.
 
The first question that the FDA is asking is whether it is ethically acceptable to conduct placebo-controlled studies in this patient population.  To me, the answer is as obvious as if the question was asked by any FDA Division of any Advisory Committee about any disease that has FDA approved drugs available to treat the disease.  That answer is NO.
 
However, I don’t understand the rest of it.  And, by the “rest of it” I mean the questions and the development strategy that led to the questions.  LAMICTAL is approved as an immediate release product as monotherapy for the treatment of partial seizures.  Why wasn’t it sufficient to do a bioequivalence study with some clinical parameters?  I understand that a “non-inferiority” trial might have been prohibitively large but the difficulties listed by the FDA with the French et al approach is like scoring a heavy weight title fight by who had the fewer missed punches.
 
That being said, it would appear that the FDA review is relatively positive with the conclusion being that the data are adequate for approval.  Let’s hope the Committee doesn’t get confused with all missed punches and can focus on the fact that all this is about is an extended release formulation of a drug that is already approved for the indication as an immediate release product.