Is the Duragesic transdermal patch recall worrisome? How about the possibility of an ultra hazardous mini-pain pump malfunction?
Posted by
Armand RossettiMarch 04, 2009 3:08 PM
Due to a Duragesic transdermal patch fold over defect, ALZA Corporation has been in the news lately. A recent FDA recall involved several lots of Duragesic with an expiration date in December 2009. Johnson & Johnson (J&J) acquired ALZA in 2001 for $10.5 billion. Another J&J subsidiary, Janssen Pharmaceutica (1961) distributes Duragesic.
The Duragesic fold over defect has caused fentanyl, which is a drug that is 80 times more potent than morphine, to leak out and to overdose unsuspecting patients. Recently, Deaths have occurred due to similar leaks from Duragesic patches, and the FDA has issued more than one warning. The thought of fentanyl leaking from Duragesic patches and taking the lives of sleeping victims seems like a bad science fiction horror story. Nevertheless, those defects seem to be lesser evils when compared to the possibilities of a Chronogesic pump mishap.
In 2000, ALZA Corporation knew that its intellectual property rights were coming to an end, and Duragesic's manufacturer probed alternative methods for delivering time-release fentanyl to patients. To accomplish this, ALZA partnered with DURECT Corporation to use DURECT’s Chronogesic implantable pump to deliver fentanyl for a very long time. To seal the deal, DURECT entered into an agreement with ALZA in which DURECT gave ALZA stock warrants, in return for a reduced future royalty and up front payments on Chronogesic sales.
DURECT’s Chronogesic pump is an implantable Titanium device the size of a wooden match stick. To market the Chronogesic, DURECT partnered with ENDO (a wholly owned subsidiary of Endo Pharmaceutical Holdings). If marketed, the Chronogesic pump would deliver Sufentanil, which is a synthetic opioid approximately 5 times more potent than fentanyl or 400 times more potent than morphine. A Chronogesic mini-pump, filled with Sufentanil and implanted under the skin could have delivered highly potent analgesic medication for up to three months.
Time release drug delivery from such a tiny pump, and over such a long period would certainly have been an amazing feat. But how much would the FDA have known about mini-pump technology and its potential pitfalls? And, what if something actually went wrong with the Chronogesic pump? If something did go wrong, Sufentanil is so potent that small amounts of it in excess of a therapeutic dose could react with the body quickly, and become irreversibly dangerous. Although the whole scenario seems unimaginable, danger in the aftermath of a Duragesic leak would pale by comparison to a Chronogesic mini-pump gone wild.
Notwithstanding the serious potential danger, those questions and thoughts are moot because Endo backed out of the deal in 2008, but not before ALZA took $13.5 million in equity from DURECT as deferred royalties and commercial rights. Thereafter, DURECT, cut its Chronogesic R&D, and wrote off the deferred royalties and commercial rights that ALZA had received.
The complexity of the pharmaceutical industry is one big, woven, tangled web to think about. In any event, something as mundane business economics and royalty write offs might have saved the day for future Chronogesic consumers.
Fortunately for all consumers, the US Supreme Court has recognized that the FDA cannot do it all when it comes to ensuring consumer safety, and the Court has ruled in favor of the Plaintiff in Wyeth v. Levine, 06-1249.