Sublingual fentanyl spray and methods of use to treat pain

• US 9,642,797 B2
• Filed: 02/12/2016
• Issued: 05/09/2017
• Est. Priority Date: 01/25/2006
• Status: Active Grant

• Current Assignee: BTcP Pharma, LLC
• Original Assignee: Insys Development Company, Inc. (INSYS Therapeutics, Inc.)
• Inventors: Kottayil, S. George, Goskonda, Venkat R., Zhu, Zhongyuan, Kattookaran, Linet, Parikh, Neha
• Primary Examiner(s): LANDSMAN, ROBERT S
• Application Number:
  US15/042,999
• Publication Number:
  US 20160193142A1
• Time in Patent Office: 452 Days
• CPC Class Codes: A61K 31/435 having six-membered rings with one nitrogen as the only ring hetero atom
• CPC Class Codes: A61K 31/445 Non condensed piperidines, e.g. piperocaine
• CPC Class Codes: A61K 31/4468 having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61M 11/00 Sprayers or atomisers specially adapted for therapeutic purposes in general B05B; aerosol containers B65D83/14
• CPC Class Codes: A61P 23/00 Anaesthetics
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.

Claims

1. A sublingual formulation comprising from about 0.1% to about 0.9% by weight fentanyl, a free base or a pharmaceutically acceptable salt thereof, or a derivative thereof, from about 20% to about 60% by weight ethanol and from about 4% to about 6% by weight propylene glycol.

2. The composition of claim 1, wherein ethanol is at a concentration from about 50% to about 60%.

3. A method of treating pain comprising administering an effective amount of the formulation of claim 1.

4. The method of claim 3, wherein the pain is breakthrough pain.