Purdue Pharma L.P. (“Purdue”) announced today that the company has partnered with MMCAP Infuse to provide buprenorphine and naloxone tablets CIII (generic Suboxone®), a medication for opioid use disorder (“MOUD”), at low cost to correctional facilities for incarcerated individuals with opioid use disorder. MMCAP Infuse is a national cooperative group purchasing organization operated by the State of Minnesota, Office of State Procurement, for government facilities that provide healthcare services. Under the agreement, to increase access to treatment for incarcerated individuals, Purdue will provide for distribution approximately 1.25 million tablets at the cost of one penny ($0.01) per tablet.

The Office of National Drug Control Policy (“ONDCP”) reports that substance use disorder affects an estimated 65 percent of incarcerated individuals, 1 and correctional facilities often face cost barriers in providing adequate substance use disorder treatment.2 Moreover, according to ONDCP, research shows that individuals leaving prison face a “meaningful elevated risk” of opioid overdose death [up to 40 times higher] than that of the general population during the first two weeks following their release.1,3 However, research also indicates that treatment with MOUDs during incarceration can reduce the risk of drug overdose death in the first month post release by 85 percent.1

“Our agreement with MMCAP Infuse supports the objectives identified by ONDCP and other government agencies that have emphasized the need to expand access to MOUD for incarcerated individuals,” said Craig Landau, MD, President and CEO of Purdue. “Unfortunately, too many in this patient population are left in need of treatment. We are committed to delivering solutions to help with this complex crisis and working with partners such as MMCAP Infuse to bring medication to those who need it most.”

This buprenorphine/naloxone tablet distribution effort is an important part of Purdue’s Public Health Initiatives, which focus on the development and distribution of medicines that reverse opioid overdoses and treat opioid use disorder. Rhodes Pharmaceuticals, a wholly owned subsidiary of Purdue, distributes this medication.

Buprenorphine and Naloxone Sublingual Tablets CIII

INDICATIONS AND USAGE

Buprenorphine and naloxone sublingual tablets are indicated for maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Buprenorphine and naloxone sublingual tablet is contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported.

WARNINGS AND PRECAUTIONS

Addiction, Abuse, and Misuse​

Buprenorphine and naloxone sublingual tablets contain buprenorphine which can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. Multiple refills should not be prescribed early in treatment or without appropriate patient follow-up visits. ​

Risk of Life-threatening Respiratory Depression and Central Nervous System (CNS) Depression​

Buprenorphine has been associated with life-threatening respiratory depression and death. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants, including alcohol, while under treatment with buprenorphine and naloxone sublingual tablets. ​Use with caution in patients with compromised respiratory function (e.g., chronic obstructive pulmonary disease, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression). Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA), sleep-related hypoxemia.

Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose

Strongly consider prescribing naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with buprenorphine and naloxone sublingual tablets and consider prescribing naloxone if the patient has household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose.

Advise patients and caregivers that naloxone may also be administered for a known or suspected overdose with buprenorphine and naloxone sublingual tablet itself. Educate patients and caregivers on how to recognize respiratory depression and, if naloxone is prescribed, how to treat with naloxone. Emphasize the importance of calling 911 or getting emergency medical help, even if naloxone is administered.

Managing Risks from Concomitant Use of Benzodiazepine or Other CNS Depressants

Concomitant use of buprenorphine and benzodiazepines or other CNS depressants increases the risk of adverse reactions including overdose and death. Medication-assisted treatment of opioid use disorder, however, should not be categorically denied to patients taking these drugs. Prohibiting or creating barriers to treatment can pose an even greater risk of morbidity and mortality due to the opioid use disorder alone. As a routine part of orientation to buprenorphine treatment, educate patients about the risks of concomitant use of benzodiazepines, sedatives, opioid analgesics, and alcohol.

Unintentional Pediatric Exposure ​

Buprenorphine can cause severe, possibly fatal, respiratory depression in children.​ Store buprenorphine and naloxone sublingual tablet safely out of the sight and reach of children.​

Neonatal Opioid Withdrawal Syndrome ​

Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy. Advise pregnant women receiving opioid addiction treatment with buprenorphine and naloxone sublingual tablets of the risk of neonatal opioid withdrawal syndrome.

Adrenal Insufficiency​

If diagnosed with adrenal insufficiency treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ​

​Risk of Opioid Withdrawal with Abrupt Discontinuation​

If treatment is temporarily interrupted or discontinued, monitor patients for withdrawal and treat appropriately. ​

Risk of Hepatitis, Hepatic Events​

Monitor liver function tests prior to initiation and during treatment and evaluate suspected hepatic events. ​

Hypersensitivity Reactions

Cases of bronchospasm, angioneurotic edema, and anaphylactic shock have been reported. The most common signs and symptoms include rashes, hives, and pruritus.

Precipitation of Opioid Withdrawal Signs and Symptoms​

An opioid withdrawal syndrome is likely to occur with parenteral misuse of buprenorphine and naloxone sublingual tablet by individuals physically dependent on full opioid agonists, or by sublingual administration before the agonist effects of other opioids have subsided. ​

Risk of Overdose in Opioid-Naïve Patients​

Buprenorphine and naloxone sublingual tablet is not appropriate as an analgesic. There have been reported deaths of opioid naïve individuals who received a 2 mg sublingual dose.

Use in Patients with Impaired Hepatic Function

Buprenorphine/naloxone products are not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment. Use of buprenorphine/naloxone may result in an increased risk of precipitated withdrawal at the beginning of treatment (induction) and may interfere with buprenorphine's efficacy throughout treatment.

Dental Adverse Events

Cases of dental caries, some severe (i.e., tooth fracture, tooth loss), have been reported following the use of transmucosal buprenorphine-containing products. Educate patients to seek dental care and strategies to maintain or improve oral health while being treated with buprenorphine and naloxone sublingual tablets.

QTc Prolongation

Thorough QT studies with buprenorphine products have demonstrated QT prolongation ≤15 msec. The risk of combining buprenorphine with other QT prolonging agents is not known. Consider these observations in clinical decisions when prescribing buprenorphine and naloxone sublingual tablets to patients with QT-related risk factors.

Impairment of Ability to Drive or Operate Machinery

Caution patients that buprenorphine and naloxone sublingual tablets may impair the mental or physical abilities required for the performance of potentially dangerous tasks such as driving a car or operating machinery.

Orthostatic Hypotension

Like other opioids, buprenorphine and naloxone sublingual tablets may produce orthostatic hypotension in ambulatory patients.

Elevation of Cerebrospinal Fluid Pressure

Buprenorphine, like other opioids, may elevate cerebrospinal fluid pressure and should be used with caution in patients with head injury, intracranial lesions, and other circumstances when cerebrospinal pressure may be increased. Buprenorphine can produce miosis and changes in the level of consciousness that may interfere with patient evaluation.

Elevation of Intracholedochal Pressure

Buprenorphine has been shown to increase intracholedochal pressure, as do other opioids, and thus should be administered with caution to patients with dysfunction of the biliary tract.

Effects in Acute Abdominal Conditions

As with other opioids, buprenorphine may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

ADVERSE REACTIONS

Adverse events commonly observed with buprenorphine and naloxone sublingual tablets include oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.

DRUG INTERACTIONS

Benzodiazepines or other Central Nervous System (CNS) Depressants: Use with caution in patients receiving benzodiazepines or other CNS depressants and warn patients against concomitant self-administration and misuse.

CYP3A4 Inhibitors and Inducers: Monitor patients starting or ending CYP3A4 inhibitors or inducers for potential over- or under- dosing.

Antiretrovirals: Patients who are on chronic buprenorphine treatment should have their dose monitored if NNRTIs are added to their treatment regimen. Monitor patients taking buprenorphine and atazanavir with and without ritonavir, and reduce dose of buprenorphine if warranted.

Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue buprenorphine and naloxone sublingual tablets if serotonin syndrome is suspected.

USE IN SPECIFIC POPULATIONS

Lactation: Buprenorphine passes into the mother’s milk. Advise breastfeeding women to monitor the infant for increased drowsiness and breathing difficulties.

Geriatric patients: Monitor geriatric patients for sedation and respiratory depression.

Moderate and Severe Hepatic Impairment: Buprenorphine/naloxone products are not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment.

Please read Full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1-888 726-7535, option 2, or FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.

Intended for healthcare professionals of the United States of America only.

About Purdue Pharma L.P.

Purdue Pharma and its subsidiaries develop, manufacture and market medications to meet the evolving needs of healthcare professionals, patients, and caregivers. Purdue’s plan of reorganization will deliver billions in value to communities across the country to fund programs specifically for abatement of the opioid crisis. The bankruptcy settlement will also deliver funds to private abatement trusts for the benefit of personal injury claimants.

Substantially all of Purdue’s assets will be transferred to a new post-emergence company with a public-minded mission. This new company will be governed by new independent board members and will operate in a responsible and sustainable manner taking into account long-term public health interests relating to the opioid crisis. The company will continue serving patients who rely on its medicines, pursuing its pipeline and introducing medicines that will help save and improve lives.

For more information, visit www.purduepharma.com.

References:

  1. The White House, Executive Office of the President, Office of National Drug Control Policy (ONDCP). National Drug Control Strategy. https://www.whitehouse.gov/wp-content/uploads/2022/04/National-Drug-Control-2022Strategy.pdf
  2. Ryan DA, Montoya ID, Koutoujian PJ, et al. Budget impact tool for the incorporation of medications for opioid use disorder into jail/prison facilities. Journal of Substance Use and Addiction Treatment. 2023;146, 208943. https://doi.org/10.1016/j.josat.2022.208943
  3. Ranapurwala SI, Shanahan ME, Alexandridis AA, et al. Opioid overdose mortality among former North Carolina inmates: 2000-2015. Am J Public Health. 2018;108(9):1207-1213. doi: 10.2105/AJPH.2018.304514.

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