This week we learn that two novel pain medications will never see the light of day:
Novartis had reached the market with the COX-II inhibitor Prexige (rebranded as the unusually positive name of Joicela), until regulators forced Novartis to pull the drug from the market in 2007. Taking a biomarker/ personalized medicine approach did not appear to appease regulators:
Joicela was resubmitted to the European watchdog with its biomarker on Dec. 3, 2009, and at the time of the withdrawal it was under review by the agency’s Committee for Medicinal Products for Human Use (CHMP).
Novartis said it had decided to pull its application because it was unable to provide the additional data requested by the CHMP within the timeframe of the current procedure.
Perhaps more disappointing was the decision by NicOx to withdraw its European application for naproxcinod, an innovative NSAID molecule which was rejected by the US FDA:
NicOx said on Wednesday it was evaluating options for the drug’s “potential further development” in Europe after an EU health expert panel said it would not adopt a formal positive opinion for its approval based on the clinical data provided.
But analysts doubted naproxcinod had any future after its double flop.
“It (naproxcinod) is dead,” says a Paris-based analyst who declined to be identified. “Now it will be wait and see what steps management will take next, how they could approach potential merger partners.”
This is rather unfortunate for chronic pain patients. A gap persists between medications to treat mild pain (acetaminophen, paracetamol) and severe pain (morphine, other opioids). Drugs such as tramadol and tapentadol have stepped into the breach, but nether of these agents are without their issues when used to treat chronic pain.
We are also aware of a highly interesting COX-II derivative with Phase II data that will also never see the light of day for fears of running into regulatory issues.
So where is the innovation in pain management? Until some novel NCEs make it, we will likely continue to see novel drug delivery-based products using established (approved) molecules. As some of our clients can confirm, there is no shortage of interest in this therapeutic area, but who will have the regulatory & clinical courage to enter the breach?
Update (May 10, 2011): There is one bit of good news. QRxPharma has recently completed Phase III enrollment for their interesting morphine / oxymorphone combination product. As mentioned, in the absence of NCEs, we need better drug delivery approaches using previously approved meds in pain management.