Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain

INSYS Therapeutics

Status and phase: Terminated; Phase 3

Conditions: Post-operative Pain

Treatments: Drug: Placebo; Drug: Buprenorphine Sublingual Spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT02310581

INS-14-026

Details and patient eligibility

About

This is a phase 3, multicenter, randomized, double-blind, multiple-dose, parallel-group, placebo-controlled study to evaluate the safety and efficacy of up to 3 dosing regimens of Buprenorphine Sublingual (under the tongue) Spray and/or matching placebo in participants with moderate to severe postoperative pain after bunionectomy. The study will comprise 4 periods: the Screening Period, the Surgical Period, the Treatment Period, and the Follow-up Period.

Participants will be admitted to the study site on the morning of the scheduled surgery, will remain at the study site until postoperative Day 3 (a total of 3 nights at the study site), and will return for the Follow-up Visit 5 to 9 days after surgery.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meets protocol-specified criteria for qualification and contraception
• Is able to speak and understand the language in which the study is being conducted, is able to understand the procedures and study requirements and has voluntarily signed and dated an informed consent form approved by the Institutional Review Board before the conduct of any study procedure
• Is willing and able to comply with study requirements (including diet, alcohol, and smoking restrictions), complete the pain evaluations, remain at the study site for three days, and return for follow up between 7 and 9 days after surgery.

Exclusion criteria

• History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters

• Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

  1. the safety or well-being of the participant or study staff
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  3. the analysis of results

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 4 patient groups, including a placebo group

Buprenorphine 0.5 mg TID

Experimental group

Description:

Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.

Treatment:

Drug: Placebo

Drug: Buprenorphine Sublingual Spray

Buprenorphine 1.0 mg BID

Experimental group

Description:

Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.

Treatment:

Drug: Placebo

Drug: Buprenorphine Sublingual Spray

Buprenorphine 1.0 mg TID

Experimental group

Description:

Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.

Treatment:

Drug: Placebo

Drug: Buprenorphine Sublingual Spray

Placebo

Placebo Comparator group

Description:

Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.

Treatment:

Drug: Placebo