It's coming -- a once-daily hydromorphone (Dilaudid), PDUFA date of Nov 22, 2009. "Exalgo will be indicated for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time."
The U.S. Food and Drug Administration approved a new painkiller from Covidien -which will hire more sales people as a result. Exalgo, a hydromorphone extended-release tablet, is intended for the treatment of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock analgesia for an extended period of time, including people suffering from low-back pain. Timothy Wright, president of pharmaceuticals at Covidien, said the company would be “significantly increasing” its branded pharmaceutical sales force in 2010 as a result of the approval of Exalgo. Covidien’s development partner, CombinatoRx Inc, develops drug candidates with a focus on the treatment of pain and inflammation. Under the agreement, Covidien, the largest supplier of controlled pain medications in the United States based on number of prescriptions, is responsible for all commercialization activities for the drug, including marketing, sales and all post-approval FDA regulatory filings.
JnJ has been selling pain medication for years going back to IV Fent-Duragesic and now Nucynta. Exalgo is a JNJ medication, we sold the rights to it in the USA, but are promoting it in Europe. Hydromorphone is a great medication. It is very clean meaning it has one of the best side effect profiles in the class. Fentanyl is probably the cleanest this is a close second. The delivery system is the key to this product. It use the OROS delivery which means you will be getting a true 24 medication. This is one of the most advanced drug delivery system on the market. If you are concerned you need to talk with your doctor or pain specialist.
Are you delusional? I know of one hospital taking dilaudid OFF their formulary; patients LOVE dilaudid...LOVE, LOVE, LOVE, LOVE.... Go to www.bluelight.ru and discover the reality, that pain management is secondary to the WHEEE factor of hydromorphone. And the Bluelight'ers will figure out in no time how to crack that OROS shell and snort the insides. Bet me. Within a few months of this stuff being out there it will be seen as Oxycontin on steroids.
Exalgo has been out there for more than a few months. REAL pain patients exist -- in case you've forgotten.
I've not forgotten...but plenty of license-protecting, paranoid physicians seem to every day. I meet too many docs who use the 10-15% of people predisposed to abuse problems as an excuse to limit their prescribing to NSAIDs and (if their poor patient is lucky) tramadol. I'm just pointing out that hydromorphone is clearly NOT the cleanest of the opium poppy extracts and a new brand name OROS system is just begging for a sensational headline.
Hydromorphone is not new. Just the delivery system (which also is not new) being married to it. It's another way to get an opioid. Now all they have to do is drop this whole "Scheduling" crap. America would be a far better place if the DEA was abolished. Some people's problem with opioids (or Schedule 1 drugs) is no excuse to conduct a war against citizens where the rights of citizens are being destroyed. Stepping off of soapbox.
I believe Exalgo is a schedule II drug like morphine and Oxycotin. If I recall heroin is the only schedule I drug that I'm aware of. That said I agree with your post. J.D.