DFN-15 (Celecoxib Oral Solution, 25 Mg/ml) in the Acute Treatment of Episodic Migraine: Efficacy Results from Two Phase III Randomized, Double-blind, Placebo-controlled Studies

Sagar Munjal, MD

AHSAM 2020 - Oral session
Published on October 2, 2020 | NEW

7 minute
4 minute

Key messages

  • Celecoxib shows efficacy as an acute treatment for episodic migraine through inhibiting prostaglandin synthesis.
  • Treatment with celecoxib, as oral solution DFN-15, resulted in significant pain reduction and migraine symptoms compared with placebo in adults.
  • DFN-15 presents no serious treatment-emergent adverse events (TEAEs) or remarkable findings in safety assessments.
  • Background

    What do we already know about this topic?
  • Findings

    What does this study add?
  • Perspectives

    How does this study impact clinical practice?
  • Expert commentary

    by A. Laine Green, MSc, MD, FRCPC, FAHS

Key messages

  • Celecoxib shows efficacy as an acute treatment for episodic migraine through inhibiting prostaglandin synthesis.
  • Treatment with celecoxib, as oral solution DFN-15, resulted in significant pain reduction and migraine symptoms compared with placebo in adults.
  • DFN-15 presents no serious treatment-emergent adverse events (TEAEs) or remarkable findings in safety assessments.

Background

What do we already know about this topic?

  • NSAIDs (nonsteroidal anti-inflammatory drugs) inhibit prostaglandin synthesis by blocking two cyclooxygenase isoforms, COX-1 and COX-2.
  • The efficacy of celecoxib, a selective COX-2 inhibitor, as an acute treatment for episodic migraine has not been established.

How was this study conducted?

  • Two identical Phase III randomized, double-blind, placebo-controlled, multicenter studies on patients (aged 18–75 years) with episodic migraine (n=631 and n=622) were conducted.
  • Patients were randomized 1:1 to DFN-15 (Celecoxib Oral Solution, 25 mg/ml, the total dose was 120 mg/ml) or matching placebo to treat a migraine with moderate-to-severe headache.
  • The co-primary endpoints were the proportion of subjects with pain freedom (moderate or severe pain at baseline goes to no-pain 2 hours post-dose) and freedom from the most bothersome symptom (MBS) at 2 hours post-dose in the first double-blind period.
  • Subjects were re-randomized into a second double-blind period and dosed at any pain level.

Findings

What does this study add?

  • The proportion of subjects pain-free at 2 hours was significantly greater with DFN-15 than placebo in Study 2 (35.6% versus 21.7%; p<0.001) but not Study 1 (32.9% versus 25.8%, p=0.075).
  • For both studies, more subjects on DFN-15 were free from MBS at 2 hours post-dose compared to placebo (Study 1, 58.9% versus 45.0%; p=0.003 and Study 2, 57.8% versus 44.8%; p=0.007).
  • Similar trends were observed for pain relief (moderate or severe to mild or no pain) at 2 hours post-dose.
  • The TEAE rates were below 14%, dysgeusia being the most common.

Perspectives

How does this study impact clinical practice?

  • DFN-15 may be an effective alternative to oral triptans for the acute treatment of episodic migraine.

Perspectives

How does this study impact clinical practice?

  • DFN-15 may be an effective alternative to oral triptans for the acute treatment of episodic migraine.

This is a highlights summary of an oral session given at the AHSAM 2020 Virtual Annual Scientific Meeting and presented by:

Sagar Munjal, MD
Vice President- Clinical development and medical affairs
Dr Reddys Inc Princeton, New Jersey

The content is produced by Infomedica, the official reporting partner of ASHAM 2020 Virtual Annual Scientific Meeting. The summary text was drafted by Goldcrest Medical Writing, reviewed by Marco Vercellino, MD, an independent external expert, and approved by Jessica Ailani, MD, FAHS and Mark J. Burish, MD, PhD, the scientific editors of the program.

The presenting authors of the original session had no part in the creation of this conference highlights summary.

In addition, an expert commentary on the topic has been provided by:

A. Laine Green, MSc, MD, FRCPC, FAHS
Assistant Professor and Staff Physician
Department of Neurology
Dartmouth Headache Center
Geisel School of Medicine at Dartmouth

A. Laine Green, MSc, MD, FRCPC, FAHS
Assistant Professor and Staff Physician
Department of Neurology
Dartmouth Headache Center
Geisel School of Medicine at Dartmouth

Dr. A. Laine Green is from Halifax Nova Scotia. His undergraduate degree was focused in organic chemistry. He then received a Master’s degree in synthetic (mechanistic) organic chemistry from Queen’s University. He completed his Medical School and Neurology residency training at Dalhousie University in Halifax. He completed his headache medicine fellowship with Dr. David Dodick at the Mayo Clinic in Arizona. His first year of fellowship was on the University of Arizona Campus in Tucson in the lab of Dr. Frank Porreca completing a preclinical project in medication overuse and cortical spreading depression. His second year of fellowship was the clinical based year with Dr. Dodick in Scottsdale. After fellowship Laine returned to Halifax where he was an Assistant Professor with the Division of Neurology at Dalhousie University for 5 years.  In late 2019 he moved to Dartmouth-Hitchcock Medical Center and Geisel School of Medicine at Dartmouth where he is an Assistant Professor in the Department of Neurology.

Headache
Headache

Scan to open on your mobile device