Long-term Open-Label Safety Study to Evaluate EN3409

BioDelivery Sciences International

Status and phase

Completed

Phase 3

Conditions

Osteoarthritis

Neuropathic Pain

Low Back Pain

Treatments

Drug: EN3409

Study type

Interventional

Funder types

Industry

Identifiers

NCT01755546

EN3409-309

Details and patient eligibility

About

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.

Enrollment

304 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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