FDA Approves Celecoxib Oral Solution for Acute Treatment Of Migraine

On May 5, 2020, the FDA approved Elyxyb (Celecoxib) for acute treatment of migraine with or without aura in adults. Celecoxib is a non-steroidal anti-inflammatory drug (NSAID). It has similar risks and side effects as other NSAIDs (like ibuprofen, aspirin, and naproxen). Elyxyb should be used as infrequently as possible to minimize side effect risks.1

What should I know about Celecoxib?

Celecoxib was first approved in 1998 to treat rheumatoid arthritis and ankylosing spondyloarthritis.2 Now, this oral liquid form of Celecoxib can be used to acutely treat migraine. It is not approved for preventive treatment of migraine. And it is not known to be safe or effective in children.3

The drug delivery system of Elyxyb allows people to take a lower dosage than with other NSAIDs. This lowers the risk of adverse effects.2 Elyxyb acts quickly, which is important for treating a migraine attack.1

How was Elyxyb studied?

Two clinical trials showed the effectiveness of Elyxyb for acute treatment of migraine. In each trial, about 600 people received Elyxyb or a placebo. Participants treated migraine with moderate to severe pain intensity.4,5

What was tested?

Both trials evaluated the success of Elyxyb 2 hours after treatment. One assessment was “pain freedom.” This is the removal of moderate or severe head pain. Another assessment was “most bothersome symptom freedom.” This is the elimination of someone’s self-identified most bothersome symptom (light sensitivity, noise sensitivity, or nausea).4,5

What were the results?

In both trials, many more people’s “most bothersome symptom” was eliminated after taking Elyxyb, compared to people taking the placebo. In one trial, many more people experienced no head pain after taking Elyxyb, compared to the placebo. The most common negative effects of Elyxyb were altered sense of taste (4.2% of people) and nausea (3.2%). There were no deaths or serious adverse effects.4,5

What are the side effects of Elyxyb?

Like other NSAIDs, Elyxyb increases cardiovascular risks, such as heart attack and stroke. It also increases gastrointestinal risks, such as stomach or intestine ulcers. These risks increase with higher doses and longer use. Gastrointestinal risks increase with ulcer history, smoking, alcohol use, old age, and combined use with some specific medications.5

Additional side effects

Additional side effects of Elyxyb include:5

  • Liver or kidney problems
  • New or worse high blood pressure
  • Life-threatening allergic or skin reactions
  • Increased asthma attacks
  • Medication overuse headaches
  • Low red blood cells (anemia)

More serious side effects

These are not all possible side effects of NSAIDs. Talk to your doctor to learn what symptoms to monitor. For example, you should stop taking Elyxyb and call your doctor if you experience these symptoms:5

Side effect emergencies

You should get emergency help if you experience these symptoms:5

  • Shortness of breath or trouble breathing
  • Chest pain
  • Weakness on one side of your body
  • Slurred speech
  • Swelling of face or throat

How should Elyxyb be taken?

When needed, you can take the appropriate dose of Elyxyb by mouth with or without food. You should not take more than one dose in a 24-hour period. And you should use Elyxyb for the fewest number of days per month. This will reduce your risk of serious side effects. You should not take Elyxyb if you:5

  • Are allergic to Celecoxib or any other ingredients in Elyxyb
  • Are allergic to sulfonamides
  • Have had an asthma attack or allergic reaction to other NSAIDs
  • Are having or just had heart surgery
  • Had a recent heart attack (unless your doctor says otherwise)
  • Are in the third trimester of a pregnancy
  • Are a woman having difficulty conceiving
  • Are using other NSAIDs

What should I tell my doctor before taking Elyxyb?

Before taking Elyxyb, you should tell your doctor about your medical conditions. This includes liver and kidney problems, stomach ulcer history, heart disease, high blood pressure, or asthma. You should also talk to them if you are pregnant, planning to become pregnant, or currently breastfeeding.

You should inform your doctor of any medications you take. NSAIDs, including Elyxyb, can interact with some other drugs and cause serious side effects. If needed, your doctor may adjust your dosage or monitor you more closely for certain side effects. Once you start taking Elyxyb, you should not take new medications without talking to your doctor.

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