Bill to deregulate buprenorphine raises concerns among OTPs

The Mainstreaming Addiction Treatment Act (H.R. 2482) would deregulate buprenorphine. Adminstration of the medication is held to high standards when used in the treatment of opioid use disorder, like methadone. Also like methadone, those standards don't apply when the medication is used to treat pain. The bill only applies to buprenorphine.     

Perils of eliminating the x-waiver: Comments from former CSAT official

A highly unusual meeting took place in 2014—a group of experts, including federal officials, and top legislators – namely, former senators Carl Levin (D-Michigan) and Orrin Hatch (R-Utah) met in June of that year to discuss changing the Drug Addiction Treatment Act of 2000 (DATA 2000), which regulated buprenorphine prescribing up until it was eviscerated in the spending bill last month (see https://onlinelibrary.wiley.com/doi/epdf/10.1002/adaw.20431 ). The lawmakers wanted to raise the maximum number of patients one physician could have (at the time, it was 30 under DATA 2000, and 100 under the 2006 amendment; since then it has been raised further).     

The implementation of buprenorphine/naloxone in college health practice

Opiate abuse and dependence have become important concerns for college healthcare providers. The passage of the Drug Addiction Treatment Act of 2000 and the approval of the combination buprenorphine/naloxone for office-based treatment of opiate dependence have increased the options available for college students and their healthcare providers. The authors review the pharmacology of buprenorphine/naloxone and discuss how it can be implemented in college health practice. They also present a case report.     

Clarification on Braeburn's CAM2038/Brixadi/Buvidal

In our recent article “Sublocade: Why a placebo arm?” (see ADAW, March 11), we referred to the investigational medication CAM2038, an injectable (weekly subcutaneous depot) form of buprenorphine that is competing with Sublocade in the buprenorphine market. To make the terminology clear, the name of the investigational medication, developed by Braeburn in partnership with Camurus (Braeburn's European partner), is Brixadi. In Europe and Australia, however, the product is approved and marketed by Camurus under the trade name Buvidal. The Food and Drug Administration (FDA) granted tentative approval to Brixadi in December 2018, but Sublocade has exclusivity. “Brixadi's clinical development program was designed with input from the FDA,” said Sonnie Kim, Pharm.D., Braeburn vice president and head of medical affairs, in an email to ADAW. CAM2038 was found effective in Phase 2 research (see ADAW, June 26, 2017). The most recent results were published in JAMA Internal Medicine ( https://jamanetwork.com/journals/jamainternalmedicine/article‐abstract/2681061 ). We regret any confusion. For more information, go to www.braeburnrx.com .     

Under 2% of Medicaid‐covered youths get MAT after OD: Study

Fewer than one‐third of youths receive addiction treatment after an opioid overdose, and only one in 54 receive pharmacotherapy (methadone, buprenorphine or naltrexone), a study published in JAMA Pediatrics reports. The researchers urge interventions to link these youths to treatment after an overdose, and call for improving access to medications: methadone, buprenorphine, and naltrexone.     

Sublocade: Why a placebo arm?

In a time when people are dying from illicit fentanyl overdoses, why would a trial for a new medication to treat opioid use disorder — a formulation of buprenorphine, already proven to be safe and effective in oral form — include a placebo arm? This was the question asked by many when the results of Indivior's trial for Sublocade, a buprenorphine injection that lasts a month, were published last month in The Lancet (see ADAW, Feb. 25). The trial results were what led to Sublocade's approval by the Food and Drug Administration (FDA) for the treatment of opioid use disorder more than a year ago (see ADAW, Dec. 11, 2017).     

Sublocade improves abstinence and quality of life outcomes

Treatment with injectable subcutaneous buprenorphine (Sublocade) over a course of a year resulted in better abstinence and quality of life, according to a study by Walter Ling and colleagues published in the current issue of the Journal of Addiction Medicine.     

Experts criticize cash‐only buprenorphine clinics,but privacy may be a reason patients like them

Making buprenorphine more accessible to patients by charging them out of pocket for it is not making it more accessible, two treatment experts noted in an editorial published in the March issue of the American Journal of Public Health. Not only is it unethical, by limiting access to those who can afford it, but it encourages diversion, they added. In fact, cash‐only buprenorphine is most likely undermining the treatment modality itself.     

Sublocade trial data published: Better than placebo

Sublocade, a buprenorphine injection that lasts a month, was approved by the Food and Drug Administration (FDA) for the treatment of opioid use disorder more than a year ago (see ADAW, Dec. 11, 2017), but the data that led to the approval was not public. It was made public in an article by Sublocade manufacturer Indivior published Feb. 18 in The Lancet.     

ADA settlement exposes liability when providers refuse MAT patients

Gov. Andrew Cuomo of New York has added opioid use disorders (OUDs) to the list of approved conditions for which medical marijuana could be prescribed in the state, following the lead last month of New Jersey Gov. Phil Murphy, who limited such use as an “adjunct” to medications like methadone and buprenorphine (see ADAW, Jan. 28).     

From starter OTP to acquisition by BayMark: A 3‐year journey

BayMark Health Services has acquired Counseling Solutions, a treatment provider focusing on methadone and buprenorphine treatment with locations in Chatsworth, Georgia, and Brasstown, North Carolina. When Zachary Talbott first started working to open his opioid treatment program (OTP) in Chatsworth more than three years ago, he had no plans to sell it (see ADAW, Aug. 17, 2015).     

Is naloxone really needed in buprenorphine product?

The word on the street has been out for some time — it's not true that the naloxone in the buprenorphine combination product (Suboxone, for example) prevents euphoria if the opioid, which is meant to be dissolved in the mouth, is ingested. More than 20 years ago, this was the premise when the federal government subsidized the development of the first buprenorphine‐naloxone product, paving the way for Reckitt Benckiser Pharmaceuticals — now Indivior — to make a fortune on its Suboxone product. There was yet another delay when the patent expired, but generic manufacturers couldn't break the code for blending the naloxone with the buprenorphine, furthering the fortunes of RBP/Indivior.     

LAC and RTI: Eliminate Medicaid prior auth for bupe

Since April 2018, Medicare limited utilization management — most often done via prior authorization requirements — for buprenorphine to treat opioid use disorder (OUD). In response, virtually all plans that covered this treatment removed prior authorization requirements. Medicaid plans should do the same, according to RTI, writing in the July 9 issue of the Journal of the American Medical Association (JAMA).     

‘Cash‐only’ buprenorphine a threat to opioid crisis

In an editorial written by the principal researcher on the clinical trials that led to the approval of buprenorphine‐naloxone to treat opioid use disorder, the increase in cash‐only buprenorphine clinics is called a threat to the opioid treatment system. “Proliferation of Cash‐Only Buprenorphine Treatment Clinics: A Threat to the Nation's Response to the Opioid Crisis,” by Art Van Zee, M.D., of the St. Charles Clinic, Stone Mountain Health Services, and David Fiellin, M.D., of the Yale University School of Medicine, was published in the March issue of the American Journal of Public Health.     

Correction

In “Is naloxone really needed in buprenorphine product?” (ADAW, June 10), there is an error. The sentence reading “But it is known that naloxone, an opioid antagonist (it is the active ingredient of Vivitrol)…” should have read “But it is known that naloxone, an opioid antagonist (it is the active ingredient of Narcan).…” We regret the error.     

DEA allows buprenorphine inductions based on telephone only

Last week, the Drug Enforcement Administration (DEA) said opioid treatment programs (OTPs) and Drug Addiction Treatment Act (DATA)–waived prescribers can treat new patients with buprenorphine based on a telephone call only. The Controlled Substances Act (CSA), enforced by the DEA, requires all new patients being treated with controlled substances to have an in‐person — or, for now, telemedicine — physical exam. Now, however, because of the coexisting COVID‐19 pandemic and opioid overdose crisis, the DEA has dropped this requirement. This follows the decision of the Substance Abuse and Mental Health Services Administration (SAMHSA) to allow exemptions from the OTP take‐home regulations allowing stable patients to be given 14 or 28 days of methadone doses, instead of coming in more frequently (see DEA, SAMHSA relax OTP/OBOT regulations due to COVID‐19, ADAW March 23, https://onlinelibrary.wiley.com/doi/10.1002/adaw.32664 ).     

Barriers to treating youth with medications for OUDs

Strategies to get medications to treat opioid use disorder (OUD) to young people immediately after diagnosis are urgently needed, a study published in the September issue of JAMA Pediatrics concluded. Young people with OUDs who receive naltrexone, methadone or buprenorphine are more likely to stay in treatment, yet these medications are underused. Only one in four youths receive medications for OUD shortly after diagnosis. For youths under 18, it's one in 21.     

Opioids,cannabis, confidentiality,ethics, buprenorphine among highlights of 2019

Opioids are still the dominant news story in the substance use disorder (SUD) field. Last year saw continued funding from the Substance Abuse and Mental Health Services Administration — and, of course, Congress — for the treatment field. Formulations of buprenorphine, the looming loss of confidentiality protections, the growing acceptance of cannabis, and a focus on quality and ethics were among the important stories for ADAW readers.     

Braeburn asks FDA to revoke Sublocade's orphan designation

Braeburn, which makes Brixadi, a buprenorphine injection, has filed a Citizen Petition calling on the Food and Drug Administration (FDA) to revoke “orphan designation” — exclusivity — for Sublocade, Indivior's injectable buprenorphine. Saying that unless the FDA does this, no competitive buprenorphine opioid use disorder (OUD) treatment will enter the market until 2024, Braeburn said the Orphan Drug Act was enacted to treat rare conditions with small patient populations. In some cases, the act is utilized even if a large population could benefit, if there is “no reasonable expectation” of recovering developing and marketing costs. Indeed, orphan drug designation (ODD) was granted to Subutex (buprenorphine) in 1994, when Indivior's predecessor was the sponsor. Now the FDA has “grandfathered” the Subutex designation to Sublocade “simply because the developer of Subutex and Sublocade is the same,” according to a press statement from Braeburn released earlier this month.