New drug for pain management

Just read this announcement and thought I'd share it with the group.

Covidien today announced that the FDA has approved the New Drug Application for EXALGO, hydromorphone Extended-Release Tablets.

The indication for EXALGO is once daily administration 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 launch of EXALGO tablets, which Covidien anticipates in the first half of calendar year 2010, will include a comprehensive Risk Evaluation and Mitigation Strategy (REMS) that is designed to ensure that the benefits of EXALGO outweigh the potential risks.

The drug will be offered through Mallinckrodt, a subsidiary of Covidien.

Thought I'd do some research on this medication so we all know what it is and what it is NOT.

Exalgo = Hydromorphone

"Hydromorphone, a more common synonym for dihydromorphinone and dimorphone, commonly a hydrochloride (trade names Palladone, Palladone SR, Dilaudid and numerous others) is a potent centrally-acting analgesic drug of the opioid class. It is a derivative of morphine, specifically a hydrogenated ketone thereof and therefore a semi-synthetic drug. It is both medically an opioid analgesic and legally a narcotic. It should not be confused with hydromorphinol, also known as 14-hydroxydihydromorphine and RAM-320 nor dihydromorphine (Paramorfan). While all of these are strong opioids, they are indeed different drugs. Additional confusion arises from the fact that in a handful of countries hydromorphinol is distributed under the trade name Numorphan, which is the trade name for oxymorphone in the rest of the world according to the current version of The A-Z Encyclopaedia of Alcohol & Drug Abuse and other references."

There will be a lot of restrictions on the dispensing of this medication so for most people it won't be as easy as getting a prescription from you doctor, filling it at the pharmacy and taking it. You will have to enroll in their program, pharmacies will go through training as will the doctors. Here's a link to more information on that topic.
updates.pain-topics.org/2009/09/new-opioid-exalgo-on-slippery-slope-of.html.

A couple of sad things I noticed were... some bloggers are happy since alcoholic beverages don't seem to have an effect on this medications. But more disturbing for me was that at least 95% of the articles online deal with the money side of this medication and very little with what it can do to help people with chronic pain.

I do hope this information helps but more than that I hope this medication comes through for those in need of pain relief and not with so many restrictions that it's impossible to get and use.

Chutz

Hydromorphone caused my breathing to slow down way too much for the amount of pain relief I was receiving.I was only on it for three days before my Dr. switched me back to morphine which has worked well for over ten years.That REM program looks like a real problem for Americans if it becomes standard practice for all opioid prescriptions.Like chronic pain patients need any more hassles than we already have......Not.

Thanks for the research Chutz. This type of information is vital when we make drug decisions. Some doctors listen to sales reps and get over inthused about potential new drugs or reformulated old ones in new dressings. It is always good to understand the medication you are taking.

Yes, I read about that too....I take Methadone along with Oxy IR 30 mg. but I'm thinking about Opana ER.  This new drug might be another option for me.

 

Me.