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Trial Underway Testing Opioid Dependency Treatments

Pills on table

(e-Magine Art/Flickr)

15 December 2015. A late-stage clinical trial testing weekly and monthly treatments of injected buprenorphine for opioid drug dependence began enrolling patients. The trial is testing the drug code-named CAM2038 developed by the pharmaceutical company Camurus AB in Lund, Sweden, and licensed to Braeburn Pharmaceuticals in Princeton, New Jersey that offers treatments for neurological conditions.

Opioids work by reducing the intensity of pain signals to the brain, particularly regions of the brain controlling emotion, which reduces effects of the pain stimulus. Examples of leading opioid prescription pain medications are hydrocodone, oxycodon, morphine, and codeine.

Abuse of opioid pain killers is described by Centers for Disease Control and Prevention as a growing epidemic, fueled in part by growing numbers of prescriptions written for pain killing drugs. CDC reports that in 2012, physicians in the U.S. wrote 259 million prescriptions for pain killers, enough for one bottle of pills for every adult in the country. As of July 2014, according to the CDC, 46 people die each day in the U.S. from an overdose of prescription pain killers. The 10 states with the highest rates of prescriptions for pain killers, says CDC, are in the South.

CAM2038 is a formulation of the drug buprenorphine that acts on the same receptors in the brain as heroin and morphine, providing enough satisfaction of those receptors without producing the intense “high” or serious adverse effects of abused drugs. Camurus adapted its injection technology that the company calls FluidCrystal for CAM2038 that combines buprenorphine with a liquid lipid solution to form a gel that that can be injected, yet breaks down slowly in the body to allow for release over extended periods of time.

CAM2038 is designed for delivery by injections under the skin by clinicians, as part of anti-addiction therapy. The formulation of CAM2038 can be adjusted for the length of time buprenorphine needs to be released, in this case either over the course of one week or one month. In 2014, Braeburn Pharmaceuticals licensed from Camurus the North American rights to CAM2038 and the companies took part in three early- and intermediate-stage trials of the drug on 176 healthy volunteers and patients.

The new trial is expected to enroll participants with opioid use disorders in a 48-week study of CAM2038, both new patients seeking treatment and individuals continuing their current buprenorphine maintenance treatments. Clinicians will be allowed to adjust dosages and switch between weekly or monthly injections as needed.

Results of the trial are expected to be part of new drug applications to both Food and Drug Administration in the U.S. and European Medicines Agency. In November, the companies began an intermediate-stage trial of CAM2038 in the U.S. testing the drug’s ability to block effects of the opioid pain medication hydromorphone in participants with moderate to severe opioid use disorders.

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