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Sublocade - possible game changer for many of us

Sat Dec 02, 2017 4:55 pm

FDA approved a new delivery system for buprenorphine a couple of days ago. Sublocade is made by Indivior (the people behind Suboxone) and is a monthly depot injection of buprenorphine. No more yucky films. Instead of taking films or tablets sublingually, you go to a clinic once a month and get your depot injection of Sublocade at a dose that's suitable. It creates a stable level of buprenorphine in the body over the month.

This has a lot of benefits both for the user, their family and society. There's a lot of fear about children overdosing on a parent's supply, which the injection prevents. It also prevents diversion to the street. Politically it removes a few points of controversy surrounding the prescription of sublingual buprenorphine.

Keep your eyes open as this could be filtering through to OST clinics in the coming months.

The U.S. Food and Drug Administration today approved Sublocade, the first once-monthly injectable buprenorphine product for the treatment of moderate-to-severe opioid use disorder (OUD) in adult patients who have initiated treatment with a transmucosal (absorbed through mucus membrane) buprenorphine-containing product. It is indicated for patients that have been on a stable dose of buprenorphine treatment for a minimum of seven days.
Buprenorphine for the treatment of OUD is currently approved to administer as a tablet or film that dissolves in the mouth, or as an implant. Sublocade provides a new treatment option for patients in recovery who may value the benefits of a once-monthly injection compared to other forms of buprenorphine, such as reducing the burden of taking medication daily as prescribed (medical adherence). An independent FDA advisory committee supported the approval of Sublocade at a meeting held last month.

"Given the scale of the opioid crisis, with millions of Americans already affected, the FDA is committed to expanding access to treatments that can help people pursue lives of sobriety. Everyone who seeks treatment for opioid use disorder deserves the opportunity to be offered the treatment best suited to the needs of each individual patient, in combination with counseling and psychosocial support, as part of a comprehensive recovery plan,” said FDA Commissioner Scott Gottlieb, M.D. “As part of our ongoing work in supporting the treatment of those suffering from addiction to opioids, the FDA plans to issue guidance to expedite the development of new addiction treatment options. We’ll continue to pursue efforts to promote more widespread use of existing, safe and effective FDA-approved therapies to treat addiction.”

Improving access to prevention, treatment and recovery services, including the full range of medication-assisted treatments (MAT), is a focus of the FDA’s ongoing work to reduce the scope of the opioid crisis and one part of the U.S. Department of Health and Human Services’ Five-Point Strategy to Combat the Opioid Crisis.

OUD is the diagnostic term used for a chronic neurobiological disease characterized by a problematic pattern of opioid use leading to significant impairment or distress and includes signs and symptoms that reflect compulsive, prolonged self-administration of opioid substances for no legitimate medical purpose or, if another medical condition is present that requires opioid treatment, the opioid is used in doses far greater than the amount needed for treatment of that medical condition.

MAT is a comprehensive approach that combines approved medications (currently, methadone, buprenorphine or naltrexone) with counseling and other behavioral therapies to treat patients with OUD. Regular adherence to MAT with buprenorphine reduces opioid withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse. At proper doses, buprenorphine also decreases the pleasurable effects of other opioids, making continued opioid abuse less attractive. According to the Substance Abuse and Mental Health Services Administration, patients receiving MAT for their OUD cut their risk of death from all causes in half.

Sublocade should be used as part of a complete treatment program that includes counseling and psychosocial support. Sublocade is a drug-device combination product that utilizes buprenorphine and the Atrigel Delivery System in a pre-filled syringe. It is injected by a health care professional (HCP) under the skin (subcutaneously) as a solution, and the delivery system forms a solid deposit, or depot, containing buprenorphine. After initial formation of the depot, buprenorphine is released by the breakdown (biodegradation) of the depot. In clinical trials, Sublocade provided sustained therapeutic plasma levels of buprenorphine over the one-month dosing interval.

The safety and efficacy of Sublocade were evaluated in two clinical studies (one randomized controlled clinical trial and one open-label clinical trial) of 848 adults with a diagnosis of moderate-to-severe OUD who began treatment with buprenorphine/naloxone sublingual film (absorbed under the tongue). Once the dose was determined stable, patients were given Sublocade by injection. A response to MAT was measured by urine drug screening and self-reporting of illicit opioid use during the six-month treatment period. Results indicated that Sublocade-treated patients had more weeks without positive urine tests or self-reports of opioid use, and a higher proportion of patients had no evidence of illicit opioid use throughout the treatment period, compared to the placebo group.

The most common side effects from treatment with Sublocade include constipation, nausea, vomiting, headache, drowsiness, injection site pain, itching (pruritus) at the injection site and abnormal liver function tests. The safety and efficacy of Sublocade have not been established in children or adolescents less than 17 years of age. Clinical studies of Sublocade did not include participants over the age of 65.

The FDA is requiring postmarketing studies to assess which patients would benefit from a higher dosing regimen, to determine whether Sublocade can be safely initiated without a dose stabilization period of sublingual buprenorphine, to assess the feasibility of administering Sublocade at a longer inter-dose interval than once-monthly and to determine a process for transitioning patients with long-term stability on a transmucosal buprenorphine dose to a monthly dose of Sublocade without the use of a higher dose for the first two months of treatment (loading dose).

Sublocade has a boxed warning that provides important safety information, including the risks of intravenous self-administration. If the product were to be administered intravenously rather than subcutaneously, the solid mass could cause occlusion (blockage), tissue damage or embolus (solid material that is carried in the blood and can become lodged in a blood vessel, which can lead to death). Sublocade must be prescribed and dispensed as part of a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the product is not distributed directly to patients. Sublocade will be provided to HCPs through a restricted program, administered only by HCPs in a health care setting, and will require health care settings and pharmacies that dispense Sublocade to complete an enrollment form attesting that they have procedures in place to ensure that Sublocade is dispensed only to HCPs and not directly to patients.

The FDA granted this application Priority Review and Fast Track designations.

The FDA granted the approval of Sublocade to Indivior Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


Re: Sublocade - possible game changer for many of us

Sun Dec 03, 2017 2:38 pm

I saw this and also was very excited. Could also be very helpful for those who have posted on here about running out of their scripts early. This would eliminate that stressor. I hope that this can be one of several options for people to use. I think if the films work fine for people they shouldn't be forced to switch. I hope it is added as another alternative so we have as many options as possible to treat our opiate use disorders. My two cents. Best

Re: Sublocade - possible game changer for many of us

Sun Dec 03, 2017 11:42 pm

I've looked over the prescribing information and diagrams, and what's interesting about Sublocade is that the levels of buprenorphine remain in the therapeutic range for some many months after the last injection. This has interesting implications for those who want to eventually come off.

On the one hand having levels that gradually decrease over many months may make it easier to taper off. On the flip side, PAWS symptoms may last an incredibly long time - even years, given low levels of buprenorphine will take an incredibly long time to leave the body.

It's really difficult to say what the end result will be, whether it will be easier or harder to come off buprenorphine via Sublocade or Suboxone. A double edged sword by the looks of things.

Re: Sublocade - possible game changer for many of us

Tue Dec 05, 2017 2:02 pm

I'm waiting to see what blood levels look like after discontinuation, but it will be helpful for discontinuation if the levels go down slowly. I am always tapering people buprenorphine and from methadone, and withdrawal can be minimized by a slow taper of 5% every 1-2 weeks.

I'm not aware of any correlation between PAWS and length of taper. My IMPRESSION is that people with severe withdrawal are more likely to have PAWS-- so a long offset of the drug may reduce that issue. PAWS is an ill-defined syndrome at best; I think at least some of the people labelled with 'PAWS' are actually struggling with major depression caused by the detox.

The main thing that determines use of the injection will be whether it is covered by insurers, and how hard it is for doctors to get it before injecting it. With the implant earlier this year, the initial deal was that doctors had to pay for the drug-- $5000 per dose-- and then get reimbursed by insurers. I would not use a medication if I have to buy it in advance and then worry about getting it covered. What if I pay $1000 for a dose, and then the patient doesn't show? Will I get my money back? Will the medication have to be returned? Who pays for shipping in that case? Does it need special handling and refrigeration?
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