For Episodic Migraine, Both OTC and New Oral Prescription Medications Provide Meaningful Pain Relief

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Both traditional over-the-counter (OTC) and newly approved oral prescription products can help patients achieve pain relief and pain freedom during an episodic migraine attack, according to research results presented at PAINWeek 2023.

Historically, the mainstay treatments for episodic migraine include combination analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), triptans, ergots, and opioids. In a study of 568 individuals representative of the US population living with migraine, researchers found that 49% use OTC products alone to treat their migraine, while 23% combine OTC and prescription products.

Although the last few years have seen the development and launch of new classes of oral prescription products, such as gepants and selective 5-HT agonists, no head-to-head comparisons between these newer products and OTC products exists.

In the current analysis, researchers reviewed published, pivotal episodic migraine studies in order to evaluate how the 2 current OTC products indicated for episodic migraine treatment—ibuprofen (400 mg) and the triple combination of acetaminophen/aspirin/caffeine (AAC; 500 mg/500 mg/130 mg)—compare to the newer oral gepants (rimegepant, 75 mg and ubrogepant, 50 mg) and selective 5-HT agonist lasmiditan, 100 mg vs placebo.

The primary efficacy endpoints of the studies included in the review were defined as measures of headache “pain relief” and “pain freedom” 2 hours after dosing. Secondary endpoints included time to pain freedom, the need for supplemental medications, sustained pain relief for 24 hours, and reductions in nausea, photophobia, and phonophobia.

Ten studies met the investigators’ inclusion criteria.

At 2 hours post-dose, all oral OTC and prescription products significantly improved the primary endpoints of pain relief and pain freedom vs placebo. In the OTC category, pain relief and freedom for the 2 products was:

• AAC vs placebo: 59.3% vs ∆26.5% and 20.8% vs ∆13.7%, respectively
• Ibuprofen vs placebo: 72.3% vs ∆22.3% and 27.7% vs ∆14.3%

Rates of pain relief and freedom from pain for the 2 gepants and lasmitidan vs placebo were:

• Rimegepant: (59.3% vs ∆16.0%) and (21.2% vs ∆10.3%), respectively
• Ubrogepant: (61.7% vs ∆13.1%) and (20.5% vs ∆7.5%)
• Lasmiditan: (62.1% vs ∆17.2%) and (29.8% vs ∆11.5%)

Researchers found that ibuprofen was associated with lower rates of pain relief (40.8% vs ∆12.7%) and freedom (13.9% vs ∆6.2%) compared with other products.

“OTC and newly approved oral [prescription] products demonstrated statistically significant better responses on both primary endpoints… compared to placebo, confirming their ability to treat episodic migraine, even though some differences in response at 2 hours post-dose between types of medications did exist,” the researchers concluded.

“OTC treatments offer convenience and affordability compared to the newer oral [prescription products,” they added. “Use of OTC products is and should remain an important part of an integrated health care approach for episodic migraine.”

This reivew was originally published on partner website Drug Topics.

Source: Mitra A, Petrusche R, Lee G. A retrospective evaluation of over-the-counter products versus recently approval oral prescription products for episodic migraine. Abstract presented at: PAINWeek; September 5-8, 2023; Las Vegas, NV.