Titan Pharmaceuticals Inc (TTNP)

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(Article In Print):Probuphine: The Solution to Opiod Addiction?
September 8, 2017
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On paper, Probuphine seems an ideal solution to the problems of opioid addiction treatment through using medication assisted treatment (MAT). Popular Science magazine agreed, naming it one of “The 12 Most Important Health Innovations of the Year” in 2016. But more than a year after being approved by the United States Food and Drug Administration (FDA), few doctors are prescribing it and a low number of opioid addicts are using it.


Benefits of Probuphine

Probuphine is a subdermal implant – four matchstick-sized ethylene-vinyl acetate rods in the upper arm – delivering a steady dose of buprenorphine. The chemical is a semi-synthetic opioid that, properly used, prevents an opioid addict from going through withdrawal and getting high. It’s been marketed by Titan Pharmaceuticals and Braeburn Pharmaceuticals in the US, using Titan’s proprietary ProNeura delivery system.

The US Drug Enforcement Agency reports that buprenorphine is among its most commonly confiscated drugs – although it is not a strong enough opioid to get one high if a user is already addicted to heroin or oxycodone, it can be enough for less experienced drug abusers. The benefit of administering the drug through Probuphine is that it eliminates the possibility such diversions, of someone else taking the medication by accident (as young children have), and of an addict missing a dose or taking too much. Nora Volkow of the US National Institute on Drug Abuse (NIDA) says it should help patients stay off other drugs and let their brain circuits recover.

The FDA approved Probuphine based on a clinical study that found only 12 percent of participants relapsed when the rods were removed (as opposed to 28 percent of the control group), and no one tried to remove the implant in an attempt to sell it on the black market.


Failed Expectations

Despite this opioid epidemic, a 2015 NIDA/National Institutes of Health (NIH) estimate found there were more than 2 million Americans with a prescription drug use disorder, costing the nation more than $78bn. In the US, Probuphine use seems to have stalled. Although Titan had already trained more than a thousand health care providers in 44 states in how to implant Probuphine by mid-June 2016, prescriptions for Probuphine were low – only 239 for the first two months, which was lower than expectations.

As of last September, CNBC analysts seemed to think that figures would increase when doctors trained in the procedure of implanting Probuphine (more than 2,400 by that time) realized that insurance companies would cover it. Health plans are already including Probuphine among their authorized treatments, including several from Blue Cross Blue Shield. But sales for later quarters have continued to be disappointing.


Drawbacks of Probuphine

Among the possible reasons for lower than expected usage figures are:

* Dosage: Currently, Probuphine is only available in an 8 mg daily dosage, while most addicts require 16 to 24 mg daily.

* Competition from Naltrexone: Vivitrol, a once-monthly injection of naltrexone, prevents addicts from getting high if they do take an opioid, but it doesn’t prevent cravings or withdrawal. Also, BioCorRx is seeking FDA approval for a naltrexone implant. Naltrexone is preferred by some doctors (and politicians) because it is not an opioid, and hence not addictive.

* Competition from Buprenorphine: Suboxone, buprenorphine as a sublingual strip of film under the tongue, works if used as prescribed. And Braeburn, half of the marketing team for Probuphine, has partnered with Camurus on CAM2038 which is an alternative long-acting buprenorphine depot.

* Familiarity: Doctors stick with what they know. Probuphine, once implanted, is difficult to remove. They may also worry about the need to insert another set of implants every six months, or of doing it wrong and getting sued.

* Cost: Probuphine is more than twice as expensive as a comparable supply of Suboxone (although it is roughly the same as the equivalent supply of Vivitrol).

* Not every addict is an “ideal” candidate. The FDA says Probuphine works best if the addict has stabilized, has been using buprenorphine for about 90 days as directed, is self-motivated and has stuck to a schedule of monthly doctor’s visits. Naturally, not every patient will fit these criteria.


Other Markets

Despite this, buprenorphine in general – and Probuphine in particular – may still catch on. Other MATs, including methadone and naltrexone, haven’t been as successful or accepted. In Australia, the Therapeutic Goods Administration (TGA) doesn’t approve naltrexone for opioid dependence except if under a “special access scheme” as a last resort (meaning the patient is likely to die otherwise, and nothing else has worked).

The ProNeura delivery platform also is in pre–clinical trials for use for other drugs and conditions, including the Parkinson’s disease medication Ropinirole and the hyperthyroidism treatment T3. Meanwhile, the Bill and Melinda Gates Foundation and Intarcia are working on a similar delivery system for HIV patients.

As drug implants become more common, their use as MAT for drug addicts will likely become more accepted. Meanwhile, Braeburn isn’t giving up. A New Drug Submission (NDS) for Probuphine was submitted to Health Canada in June this year, and a Marketing Authorization Application (MAA) is being prepared for the European Medicines Agency (EMA) in the fourth quarter.



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