Tuesday, January 6, 2015

Another New Opioid: Cheeky, This One

Yesterday, I wrote about generics and the distraction of cheap, but still potentially dangerous, medications.  Never fear: there's always an expensive new brand name drug with which to contend.

On December 23, Endo Pharmaceuticals put out a press release announcing that the company has filed a New Drug Application with the FDA for Buprenorphine HCI Buccal Film for the "management of pain severe enough to require daily, round the clock, long-term opioid treatment and for which alternative options were inadequate" (the precise language required on the labeling of any extended release/long acting opioid).  The buccal film will be a strip placed on the inside of the patient's cheek.

According to Endo, this medication is a "partial opioid agonist and a potent analgesic."  Let's break those phrases down so you know what you'll be dealing with if this gets approved.

A partial opioid agonist means that although buprenorphine is an opioid, and thus can produce effects similar to other opioids (more on that next), its effects are less than those of "full agonists" like heroin or methadone.  Many of you will recall buprenorphine as a primary ingredient of Suboxone, a medication indicated for helping patients wean off of other opioids.

But Endo isn't intending this medication to assist in the weaning process.  Rather, Endo is also describing this as a "potent analgesic," with all of the issues associated with other long acting opioids.  The press release does say that the medication demonstrated a "low incidence of typical opioid like side effects."  No mention of the specific side effects or what "low incidence" actually means.

Next, look for the marketing folks to put an inspiring and cool-sounding trade name on this.  For now, we have Exalgo... Nucynta...  Opana... Zohydro... Hysingla... Palladone... This list would be hilarious if it wasn't so tragically true.

Any guesses for this new one?

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