Med Check

FDA Approves First Implant For Opioid Dependence

The Food and Drug Administration (FDA) has approved the first buprenorphine implant for the maintenance treatment of opioid dependence.

The implant, known as Probuphine, is designed to be surgically placed under the skin inside the upper arm to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine as part of a medication-assistant treatment program.

A randomized clinical trial of adults aged 16 to 65 who met the clinical criteria for opioid dependence and were considered stable after prior buprenorphine treatment found 63 percent of patients treated with Probuphine had no evidence of illicit opioid use throughout six months of treatment—similar to the 64 percent of patients who responded to a daily sublingual form of the medication.

The most common side effects from treatment with Probuphine included headache, depression, constipation, and pain at the site of the implant.

Probuphine can be prescribed, dispensed, inserted, and removed only by health care providers who are certified in the Probuphine Risk Evaluation and Mitigation Strategy program and have completed additional training.

Probuphine is marketed by Titan Pharmaceuticals Inc. and Braeburn Pharmaceuticals.

Nicopure Labs Challenges FDA’s Move to Regulate e-Cigarettes

Nicopure Labs LLC, a leading manufacturer of e-liquids (fluids used in e-cigarettes), last month filed the first legal challenge to the FDA’s move to expand the agency’s regulation to include e-cigarettes and cigars.

Nicopure Labs claims that the rulemaking process used by the FDA violated the Administrative Procedure Act, which governs internal procedures of administrative agencies, and that the new regulation violates the company’s First Amendment rights by inhibiting the company’s engagement in other forms of protected expression, including distribution of free samples of vaping devices or e-liquids.

The new rule, which goes into effect August 1, requires product manufacturers to put health warnings on product packaging and advertisements, and prohibits sales to individuals under the age of 18. The new rule also requires e-cigarette manufacturers to meet premarket approval requirements, meaning they will either have to show their e-cigarettes are appropriate for the protection of public health or their products are similar to those on the market as of February 15, 2007.

“FDA’s rule does not protect the consumer from low-quality products; instead, it places a disproportionate and unjustified regulatory burden on compliant companies such as ourselves, who are determined to drive the industry to the highest standards of quality and innovation,” stated Jason del Giudice, the company’s chief technology officer and cofounder, in a press release.

According to The Hill, other manufacturers of related products are reviewing what options they have to fight back against a rule they say will stifle product innovation.

NIDA Launches Online Resource for Naloxone

In response to the public demand for tools and information to help thwart the nation’s current opioid overdose crisis, the National Institute on Drug Abuse (NIDA) has created a web section dedicated to resources about the opioid overdose reversal medication naloxone.

The web resource describes FDA-approved formulations of the opioid antagonist, including Evzio (a prefilled auto-injection device) and Narcan Nasal Spray (a prefilled, needle-free device that delivers naloxone into one nostril).

The naloxone web page also includes links to pharmacies that offer naloxone (with and without a prescription) and laws regarding naloxone in different states; more information about what to expect when administering naloxone and potential side effects of the medication are also included.

According to NIDA, more than 18,000 overdose deaths from prescription pain relievers and 10,000 overdose deaths from heroin took place in 2014.

The naloxone web resource page can be accessed here.

Boehringer Ingelheim Launches Research Initiative On Psychiatric Disorders

Boehringer Ingelheim recently teamed up with BioMed X to bring together an international team of scientists with the goal of creating new therapies for treating psychiatric disorders.

The newly formed interdisciplinary team will work with Boehringer Ingelheim’s internal research and development division to create a highly integrated brain microcircuit model, including neuronal and non-neuronal cells, with the intention of uncovering novel therapies for psychiatric diseases.

Boehringer Ingelheim will sponsor the research for two years with the option to extend the funding period up to a total of four years.

The research will be based at the BioMed X Innovation Center located on the campus of the University of Heidelberg, Germany.

The members of the newly formed team were selected based on the ideas they presented in a crowdsourcing competition. ■