Narcotic analgesics:
Indications for: NUCYNTA ER
Management of pain or neuropathic pain associated with diabetic peripheral neuropathy (DPN) severe enough to require daily, around-the-clock, long-term analgesia for which alternative treatment options are inadequate.
Limitations of Use:
Not for use as an as-needed (prn) analgesic. Use only if alternative treatment options (eg, non-opioid analgesics, immediate-release opioids) are ineffective, not tolerated, or otherwise inadequate to provide sufficient management of pain.
Clinical Trials:
Moderate to Severe Chronic Low Back Pain (LBP)
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The efficacy and safety of Nucynta ER was evaluated in a randomized, double-blind, active- and placebo-controlled studies in patients 18 years of age and older with chronic low back pain and a baseline pain score of at least 5 on an 11-point numerical rating scale (NRS), ranging from 0 to 10. Patients were randomly assigned to 1 of 3 treatments: Nucynta ER, active-control (an extended-release Schedule II opioid analgesic), or placebo.
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Patients who received Nucynta ER achieved a significantly greater reduction in pain after 15 weeks compared with placebo.
Neuropathic Pain Associated with Diabetic Peripheral Neuropathy (DPN)
Two DPN studies (Study DPN-1; Study DPN-2) included patients 18 years of age or older with pain due to DPN and a pain score of ≥5 on an 11-point numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Following an open-label treatment period in which Nucynta ER was administered to all patients for 3 weeks and titrated to an individually stable dose, patients who had tolerated the drug and demonstrated at least a 1-point improvement in pain intensity on the NRS at the end of the open-label titration period were randomized to either continue the Nucynta ER dose (100 mg to 250 mg twice a day) reached during the open-label titration period, or receive placebo for 12 weeks of maintenance treatment.
Study DPN-1:
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591 patients entered an open-label treatment; of which, 389 patients were randomized into the double-blind treatment period.
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After 12 weeks, Nucynta ER achieved a significantly greater reduction in pain compared with placebo.
Study DPN-2:
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459 patients entered an open-label treatment; of which, 320 patients were randomized into the double-blind treatment period.
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After 12 weeks, Nucynta ER achieved a significantly greater reduction in pain compared with placebo.
Adult Dosage:
Use lowest effective dose for shortest duration. Swallow whole. ≥18yrs: Individualize. Usual dose: 100–250mg twice daily (approx. every 12hrs). Opioid-naïve or opioid non-tolerant: initially 50mg twice daily (approx. every 12hrs); titrate to optimal dose. Max 500mg/day. Converting from Nucynta to Nucynta ER: divide total daily dose of Nucynta into two equal doses of Nucynta ER separated by 12hr intervals. Converting from other opioids: see full labeling. Moderate hepatic impairment: initially 50mg once every 24hrs; max 100mg/day. Withdraw gradually (esp. if opioid-dependent), taper by ≤10–25% every 2–4 weeks.
Children Dosage:
<18yrs: not established.
NUCYNTA ER Contraindications:
Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus. During or within 14 days of MAOIs.
Boxed Warning:
Addiction, abuse, and misuse. Risk evaluation and mitigation strategy (REMS). Life-threatening respiratory depression. Accidental ingestion. Neonatal opioid withdrawal syndrome. Risks from concomitant use with benzodiazepines or other CNS depressants.
NUCYNTA ER Warnings/Precautions:
Assess the potential need for access to naloxone when initiating and renewing therapy. Consider prescribing naloxone based on risk factors for overdose (eg, history of opioid use disorder, prior opioid overdose, household members or other close contacts at risk for accidental ingestion or overdose). Abuse potential (monitor). Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. Accidental exposure may cause fatal overdose (esp. in children). Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Hepatic or renal impairment in children: not recommended. Severe renal or hepatic impairment in adults: not recommended. Consider reducing current opioid analgesic dose or rotating opioid if opioid-induced hyperalgesia is suspected. Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Drug abusers. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery: not recommended. Nursing mothers: monitor infants if used; for ER tabs: not recommended.
See Also:
NUCYNTA ER Classification:
Opioid agonist.
NUCYNTA ER Interactions:
See Contraindications. Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor closely; consider prescribing naloxone if concomitant use is warranted. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, cyclobenzaprine, metaxalone, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and/or precipitate withdrawal symptoms. May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics.
Adverse Reactions:
Nausea, constipation, dizziness, vomiting, headache, somnolence; respiratory depression, severe hypotension, syncope, opioid-induced hyperalgesia. Also in children: pruritus, pyrexia.
Drug Elimination:
Renal (99%). Half-life: 5 hours. Clearance: 1603 +/- 227 mL/min.
REMS:
Generic Drug Availability:
NO
How Supplied:
Tabs—100; ER tabs—60
