"These patients must meet strict criteria and have no known or pre-existing heart problems and be in critical need of this drug," said Steven Galson, M.D., M.P.H., director of FDA’s Center for Drug Evaluation and Research (CDER). "Zelnorm will remain off the market for general use."
You may recall that there are two patient types for IBS – one whose suffering is characterized by diarrhea and one by constipation. Coincidentally, at nearly the same time, there were two medications devised to treat IBS – Lotronex, manufactured by GlaxoSmithKline and Zelnorm.
Lotronex experienced some safety-related issues once it was approved and was subsequently pulled from the market. However, it returned to the market under a patient safety risk management program.
Much later, Zelnorm also was perceived to have a safety related issue – this one heart attack related and on March 30, the FDA asked that it be pulled from the market. However, as of Friday, it returns, albeit to a more limited population of patients laid out by terms and conditions specified by FDA.
Zelnorm and Lotronex returned to market under different circumstances – the former under a treatment IND and the latter under a risk management program.
What does it take to return a product to market? This may not be a complete list, nor or all of these necessary, but here are characteristics that help make the case.
- Fill Unique Role – It doubtless helped both of these drugs considerably that the conditions they treat do not have other drugs that fulfill this role. In other words, suffering patients were without choice.
- Provision of Clear Benefit – Here both drugs provided a clear benefit to patients that needed to be re-evaluated against newly discovered risks or perceived risks.
- Vocal Patient Population – The Lotronex patients, in particular, were very vocal and formed a pretty solid group going into the FDA hearing on the risk management plan necessary to re-introduce Lotronex. There was some very moving and effective patient testimony given during that meeting that put a human face on a condition many might otherwise be inclined to minimize.
- Companies Willing to Compromise – A company may not agree with the risk assessment, but it also may be tempting for a company to take the matter so seriously and personally, that they are unwilling to compromise. Here, in both instances, the companies were willing to accept limitations to their marketing of drugs in order to get patients what they needed. These were both mature and FDA-experienced companies, whereas a small start-up or single product company might not be so pliant.
Novartis is providing further information on Zelnorm at its site.