Chronic Pain Medication Options Expanded by FDA

Chronic Pain Medication Options Expanded by FDA

The FDA has approved a new option for treating chronic pain.

BioDelivery Sciences International, Inc. (BDSI) and its partner Endo Pharmaceuticals Inc. (Endo), a subsidiary of Endo International plc (ENDP) (ENL.TO), announced the U.S. Food and Drug Administration (FDA) approved BELBUCA™ (CIII) (buprenorphine HCl) buccal film for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.

“There is a need for alternative therapies, especially as half of the chronic pain sufferers using opioids do not feel they get consistent pain relief,” said Heather  Zoumas Lubeski, Senior Director of Corporate Affairs at Endo.  “BELBUCA™ presents a unique approach for chronic pain management, combining the proven efficacy and established safety of buprenorphine with a novel buccal film delivery system that adds convenience and flexibility.”

Chronic pain affects more than 100 million Americans – more than diabetes, heart disease and cancer combined – with one in three experiencing persistent pain. Annually, the U.S. chronic pain market is approximately $13 billion with the majority of sales and prescriptions (130 million scripts) for opioids.

BELBUCA will be available in early 2016. Its lower abuse potential is being touted by both companies.

“BELBUCA will provide a novel, alternative treatment option for millions of people suffering with chronic pain.  Clinical trials demonstrated that twice daily administration of BELBUCA was well tolerated and controlled moderate to severe chronic pain.  BELBUCA will also provide healthcare practitioners and their patients with a new buprenorphine treatment option. Buprenorphine is a Schedule III controlled substance, meaning that it has been defined as having lower abuse potential than Schedule II drugs, a category that includes most opioid analgesics,” stated Dr. Andrew Finn, Executive Vice President of Product Development at BDSI.

The product is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment, those with known or suspected gastrointestinal obstruction (including paralytic ileus), and hypersensitivity (anaphylaxis) to buprenorphine.

Image courtesy of BioDelivery Sciences.

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Authored by: Ed Coghlan

There are 7 comments for this article
  1. Lisa Shands at 7:18 pm

    I have used the button patch and it is the only medication that relieves my chronic pain but I am allergic to the patch itself, I would like to try buccal

  2. Medea Karr FNP at 12:29 pm

    We have been prescribing buprenorphine off-label for chronic pain for a number of years now, and for some patients it is very effective! I’m not usually a fan of drug companies spending exorbitant amounts of money redesigning existing generic medications so they can make huge profits. But in this case I do see a side benefit: if the FDA approves this for pain that means more insurance companies will start reimbursing for buprenorphine for pain! Until now Medicare and Medicaid have only covered it for opioid addiction, so those patients are having to pay around $300/month for the generic version. This could be a huge savings for the patients who do really well on it.

    While I’m here I’ll try to address some of the questions and concerns mentioned by other commenters, so here are a few facts about buprenorphine in general:

    1. Buprenorphine can’t be used orally because it has very poor absorption in the GI tract, so this is why it needs to be prepared in a buccal (absorbed through your cheeks and gums) or sublingual or dermal patch form. Sublingual is the route we have historically used for more severe pain because we can go higher with the dose. The butrans dermal patch is designed for less severe pain, so it’s not strong enough for some patients.

    2. The medication doesn’t tend to provide as much of the “high” or euphoria that an addict would be seeking. It is still a controlled medication and it is possible to abuse it, but it is not considered quite as desirable for this purpose as the schedule II drugs. Also most people with chronic pain don’t tend to get a “high” effect from their daily pain meds, unless they are taking more than they need or combining them with other substances.

    3. There is a version of the drug that is combined with narcan to minimize risk of addicts using other opioids while they are on it (Suboxone). But in pain management we usually use the plain version, unless the patient also has addiction issues. So the plain buprenorphine mentioned in the article does not have narcan in it. Also FYI narcan doesn’t cause people to stop breathing if combined with an opioid – it just blocks the opioid receptors so the opioid won’t work. In fact it’s what we use to reverse overdoses, so it actually does just the opposite – it reverses opioid induced respiratory arrest.

    4. I’m not sure about the dosage of the new version of the med, but I can tell you that buprenorphine has a very long half life, so each dose lasts much longer than most other opioids. Most people only take it once or twice a day.

    I hope this helps to clear up some of the questions about this medication, and I really hope more folks will be able to access pain relief with this new FDA approved use of buprenorphine. It’s certainly not for everyone, but it’s great to have more options available!

  3. Kristi at 5:54 pm

    This med is the same as a Butrans patch. I understand using it by buccal, it will get faster into your system, but my question is how much faster and how many times per day can you use this, what is the half life etc. The Butrans patch is just the same as this and all you do is stick it on an area of your body and it delivers directly into the blood stream, kinda like this buccal patch would be doing. I would rather wear my Butrans patch and change it every 5 days instead of 7, which I do because it doesn’t last me the full 7 days. And as a chronic pain patient with a genetic disease, I wouldn’t trust these buccal patches just yet. I would seriously think this buccal patch could lead to more of an addiction (like waiting for the “high” for pain relief) and then people may go on to using other types of recreational meds. I’m just not too sure yet and I’m not trying to be judgmental before this is put out into the chronic pain community. But I have my doubts because not only will it dissolve fast, but how long will it stay active in the system? And will people use more because it doesn’t stay as active as your typical Butrans patch? I guess we will find out!

  4. Patty at 6:27 pm

    This is not a drug I would feel safe taking. It’s basically methadone and narcan.
    It’s used for IV drug abusers to stop withdrawal. Because of the narcan effect the abuser can’t get high, and will stop breathing if they try.
    I do not see this as an “option” for myself.

  5. Cyndi at 3:38 pm

    More information please. How is it used? Thank you.

  6. Kathy at 2:21 pm

    Is that something implanted into your skin? I’d try it