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Indivior's monthly injectable buprenorphine formulation Sublocade gets US FDA approval to treat opioid use disorder

Slough, UK
Saturday, December 2, 2017, 14:00 Hrs  [IST]

Indivior has announced that the US Food and Drug Administration (FDA) has approved Sublocade (buprenorphine extended- release) injection for subcutaneous use (CIII), the first and only once-monthly injectable buprenorphine formulation for the treatment of moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a transmucosal buprenorphine-containing product followed by dose adjustment for a minimum of seven days.

Sublocade is intended to be administered only by healthcare providers and should be used as part of a complete treatment program that includes counseling and psychosocial support. Sublocade is expected to be available to patients in the US in Q1 2018.

“Sublocade is a scientific innovation that represents a new treatment option to help patients attain more illicit opioid-free weeks during their treatment program,” said Shaun Thaxter, chief executive officer of Indivior. “In the Opioid Blockade Study, Sublocade achieved complete blockade of drug-liking effects for a full month in most patients. Sublocade is the first and only therapy that, at steady state, delivers buprenorphine at a sustained rate of at least 2 ng/mL over a one month period. The urgency for this new treatment has never been greater, as the US opioid crisis has been declared a national public health emergency. Sublocade’s approval is an important step forward for patients, families and communities battling the opioid epidemic.”

Sublocade contains buprenorphine, a partial agonist at the mu-opioid receptor. Mu-opioid receptors in the brain are known to mediate the subjective effects of opioids, including drug-liking, which is the pleasure associated with opioid use. Sublocade delivers sustained plasma levels of buprenorphine that translate into high mu-opioid receptor occupancy in the brain, which blocks the drug-liking effects of opioids.

In the Sublocade clinical trial program, average buprenorphine plasma concentrations of 2-3 ng/mL were associated with mu-opioid receptor occupancy =70% and the reduction of illicit opioid use.  Sublocade 300 mg delivers average buprenorphine plasma levels of approximately 2 ng/mL after the first injection. The average concentration of Sublocade at steady-state was 3.21 ng/mL and 6.54 ng/mL for the 100 mg and 300 mg doses, respectively.

Indivior conducted an Opioid Blockade Study (RB-US-13-0002) which investigated the ability of Sublocade 300 mg to block the subjective effects of illicit opioids, including drug-liking. In the 12-week trial evaluating the blocking effect, Sublocade 300 mg fully blocked the drug-liking effects of hydromorphone. Hydromorphone is a potent opioid pain medication that is commonly used in human studies to evaluate opioid drug-liking.

Sublocade was evaluated in a 24-week, phase 3 pivotal study (RB-US-13-0001) in which patients were randomized to one of the following three regimens: six once-monthly Sublocade 300 mg doses; two once-monthly Sublocade 300 mg doses followed by four once-monthly 100 mg doses; or six once-monthly injections of placebo. Both dosage regimens of Sublocade were shown to be superior to placebo in achieving more illicit opioid-free weeks (p<0.0001). In the clinical trials, the overall safety profile for Sublocade, given by a healthcare provider, was consistent with the known safety profile of transmucosal buprenorphine, except for injection site reactions. The most common adverse reactions (=5% patients), included constipation, nausea, vomiting, abnormal liver enzymes, headache, sedation and somnolence. Injection site reactions were reported in 16.5% of the patients.  None of the injection site reactions were serious, and only one led to study treatment discontinuation1.

“Every patient’s journey to recovery is different and they face many challenges. To help support these differences, doctors and patients need options for medication-assisted treatment,” said Dr. Brent Boyett, Sublocade clinical investigator and director at Boyett Health Services, Inc. “In a phase 3 clinical study, Sublocade helped patients refrain from illicit opioids for more weeks compared to placebo. Used in combination with counseling and psychosocial support, Sublocade is a transformational new drug that offers a treatment option for people with moderate to severe opioid use disorder.”

The opioid addiction epidemic in the US is a national public health emergency, with nearly 12 million people impacted nationwide and an average of four people dying from opioid overdose every hour of every day5,6,7. OUD, commonly referred to as opioid addiction, is a chronic disease that changes the brain. The patient journey to treatment and recovery is complex, with many barriers such as social stigma, access to treatment and prescribers, and difficulty adhering to treatment plans. Out of the more than 2.5 million patients diagnosed with OUD in the US, less than half are treated with medication-assisted treatment (MAT).

The economic impact of the opioid epidemic to the healthcare system is significant. The amount paid for treatment of substance use disorders is only a small portion of the costs these disorders impose on society. Data published in 2016 presented the total costs of prescription opioid use disorder and overdose in the U.S. at $78 billion in 2013. Of that, only 3.6 percent, or about $2.8 billion, was for treatment. A separate, recent analysis by the White House Council of Economic Advisers estimated the total annual cost of prescription opioid overdose, abuse and dependence in the US at $504 billion in the year 2015. Patients, physicians, policymakers and other stakeholders have expressed the need for additional treatment options in the fight against the chronic relapsing disease of opioid addiction. Indivior has an ongoing, prospective, observational study (RECOVERTM) to understand the clinical, environmental and socioeconomic characteristics of OUD patients.

“The American Society of Addiction Medicine supports the development and manufacturing of medications that aid in the treatment of addiction,” said Dr. Kelly Clark, President, American Society of Addiction Medicine. “The introduction of novel pharmacotherapies supports this goal. Addiction patients, like all patients, should have available to them a robust and varied array of treatment options, as no one treatment modality is appropriate or therapeutic for everyone.”

“We applaud the scientists and leaders who have been working tirelessly on the development of new, longer-acting medicines for the treatment of opioid use disorder. These exciting new developments will help our patients and families live healthy lives and accelerate the progress in the treatment of addiction,” commented Jessica Hulsey Nickel, president and chief executive officer of the Addiction Policy Forum.

Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of Sublocade in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.

Sublocade will be distributed through a restricted distribution system, which is intended to prevent the direct distribution to a patient. This is because of risk of serious harm or death that could result from intravenous self-administration.

Indivior worked closely with the FDA to include appropriate warnings and precautions, including a Boxed Warning in the label and implementation of a Risk Evaluation and Mitigation Strategy (REMS) program. Healthcare settings and pharmacies that order and dispense Sublocade must be certified in the Sublocade REMS Program. In addition, Indivior continues to enhance its compliance program to keep pace with the anticipated increase in the number of patients in treatment.

 

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