Long-term Open-Label Safety Study to Evaluate EN3409
Condition: Low Back Pain; Osteoarthritis; Neuropathic Pain
MeSH terms: Osteoarthritis; Neuralgia; Back Pain; Low Back Pain
Intervention: EN3409
Intervention description: Open-Label Buprenorphine HCI Buccal Film at doses 300-900 mcg twice daily
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 304.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Pain; CLBP; Chronic Low Back Pain; Back Pain; Osteoarthritis; OA; Neuropathic Pain; Nerve pain; Painful neuropathy

Summary:

      The purpose of the long-terms study is to evaluate the safety, tolerability, and analgesic
      efficacy of EN3409 in subjects with moderate to severe chronic pain requiring continuous
      around-the-clock opioid analgesia for an extended period of time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects who are practicing abstinence or using a medically acceptable form of
             contraception or have been postmenopausal, biologically sterile, or surgically sterile
             for more than 1 year

          -  Male subjects who are practicing abstinence, surgically sterile, or are using a
             medically acceptable form of contraception

          -  De Novo subject with a clinical diagnosis of moderate to severe noncancer-related CP
             (eg, CLBP, OA, neuropathic pain) for ≥ 3 months

          -  De Novo subject that is treating their CP with a stable daily maintenance dose of ATC
             opioid analgesic medication equivalent to ≥ 60 mg and ≤ 160 mg Morphine Sulfate
             Equivalent (MSE) per day for ≥ 4 weeks

          -  Stable health, as determined by the Principal Investigator

          -  Subject is willing and able to comply with all protocol required visits and
             assessments

          -  Rollover subject who has completed the 12-week Double-blind Treatment Phase in the
             EN3409-307/308 clinical study

        Exclusion Criteria:

          -  A history or current evidence of any clinically significant disorder or any other
             condition, which in the opinion of the investigator, would jeopardize the safety of
             the subject or impact the validity of the study results

          -  Females who are pregnant, breastfeeding, or plan to become pregnant during the study

          -  Current cancer-related pain or received chemotherapy within 6 months of screening

          -  Subjects receiving opioid analgesic medication < 60 mg MSE per day within 28 days of
             screening

          -  De novo subjects receiving opioid analgesic medication at doses of > 160 mg MSE per
             day within 28 days of screening

          -  Subjects with a history of other chronic painful conditions, other than the index CP
             condition, which require frequent analgesic medication

          -  Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute
             spinal cord compression, cauda equina compression, acute nerve root compression,
             meningitis, or discitis

          -  History of allergy or contraindications to any opioid or acetaminophen

          -  Surgical procedure for relief of pain within 6 months, or nerve/plexus block within 28
             days of screening

          -  Hypokalemia or clinically unstable cardiac disease

          -  Moderate to severe hepatic impairment

          -  Moderate to severe renal impairment

          -  Current or past history of alcohol or substance

          -  Positive urine toxicology screen for drugs of abuse

          -  History of abnormalities on physical exam, vital signs, ECG, or lab values