COX-2 inhibitors

Dr. Reddy’s Laboratories Announces Entry Into Definitive Agreement with BioDelivery Sciences International, Inc., to Sell its U.S. and Canada Territory Rights for ELYXYB (celecoxib oral solution) 25 mg/mL

Retrieved on: 
Wednesday, August 4, 2021

Under the terms of agreement, Dr.Reddys will receive U.S.$6 million upfront upon closing followed by U.S.$9 million one year from closing.

Key Points: 
  • Under the terms of agreement, Dr.Reddys will receive U.S.$6 million upfront upon closing followed by U.S.$9 million one year from closing.
  • ELYXYB (previously known as DFN-15) is indicated for the acute treatment of migraine with or without aura in adults.
  • ELYXYB is an oral solution dosage form which makes it convenient for patients to take it immediately upon emergence of migraine attacks.
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal.

Antibe Therapeutics Receives FDA Clearance of IND Application for Otenaproxesul for Osteoarthritis Pain

Retrieved on: 
Monday, March 29, 2021

This enables Antibe to undertake human clinical trials in the U.S.; as previously announced, Antibe anticipates initiating its Phase III program later this year.

Key Points: 
  • This enables Antibe to undertake human clinical trials in the U.S.; as previously announced, Antibe anticipates initiating its Phase III program later this year.
  • We are pleased to have been authorized to proceed with our clinical program for otenaproxesul, commented Dr. Joseph Stauffer, Antibes Chief Medical Officer.
  • Antibes lead drug, otenaproxesul, is entering Phase III for the treatment of osteoarthritis pain.
  • Additional assets under development include a safer alternative to opioids for peri-operative pain, and a GI-protective alternative to low-dose aspirin.

Burke Therapeutics, LLC Signs Exclusive US Marketing and Supply Agreement with Coeptis Pharmaceuticals, Inc. for Consensi®

Retrieved on: 
Wednesday, March 11, 2020

Burke Therapeutics, LLC, a commercial stage pharmaceutical company, today announced it has signed an exclusive marketing and supply agreement with Coeptis Pharmaceuticals, Inc. for the U.S. market.

Key Points: 
  • Burke Therapeutics, LLC, a commercial stage pharmaceutical company, today announced it has signed an exclusive marketing and supply agreement with Coeptis Pharmaceuticals, Inc. for the U.S. market.
  • The U.S. Food & Drug Administration (FDA) approved Consensi oral tablets for marketing on May 31, 2018.
  • Consensi is indicated for adult patients for whom treatment with both amlodipine for hypertension and celecoxib for osteoarthritis are appropriate.
  • You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

BioElectronics Files FDA 510(k) Application for Musculoskeletal Pain Complaints; Clinical Data Demonstrates Superior Drug Free Pain Relief to Prescription Strength NSAID Drug

Retrieved on: 
Tuesday, August 20, 2019

The application is to seek expanded market clearance for the drug free, over-the-counter ActiPatch Musculoskeletal Pain Therapy medical device for the indication: adjunctive treatment of musculoskeletal complaints pain.

Key Points: 
  • The application is to seek expanded market clearance for the drug free, over-the-counter ActiPatch Musculoskeletal Pain Therapy medical device for the indication: adjunctive treatment of musculoskeletal complaints pain.
  • The cervical osteoarthritis (neck pain) study submitted directly compares the effectiveness of ActiPatch treatment to that of a standard of care treatment: prescription NSAID (Cox-2 inhibitor) therapy, Etoricoxib 60mg (like Celebrex).
  • Data from the study indicates that both treatments significantly reduced neck pain, but that ActiPatch was superior to NSAID treatment (statistically significant).
  • The ActiPatch is already FDA-cleared for over-the-counter treatment of pain from knee osteoarthritis and plantar fasciitis (heel pain).