Watch for Gepirone ER, a New Rx Antidepressant

Gepirone ER (Exxua) will be a new Rx med for depression in adults.

Gepirone works similarly to the anxiety med buspirone.

Reps will tout that gepirone doesn’t have a warning about sexual dysfunction...which is common with other antidepressants (paroxetine, etc). But there’s no good evidence that sexual side effects are less.

Plus gepirone has a checkered history.

FDA rejected it 3 times over 20 years...due to a stack of studies that don’t find any benefit. Its approval now is based on 2 studies showing efficacy at 8 weeks...but there aren’t good long-term data.

On top of that, about a third or more of patients taking gepirone ER report dizziness, nausea, or headache.

Expect that most adults with depression will still get a first-line treatment...such as an SSRI (sertraline, etc) or SNRI (duloxetine, etc).

If you get an Rx for Exxua, anticipate payer rejects. It’ll likely cost at least $500/month...versus about $15 for generic SSRIs or SNRIs.

Watch out for look-alike/sound-alike meds. Exxua could be mistaken for Euflexxa or Andexxa...or gepirone for buspirone.

Double-check strengths of Exxua during order entry. The ER tabs come in 4 strengths, 18.2 mg...36.3 mg...54.5 mg...and 72.6 mg.

Expect most patients to start with one 18.2 mg tablet by mouth once daily...and increase based on response and tolerability.

For example, the dose may go up to 36.3 mg once daily on day 54.5 mg after day 7...and to 72.6 mg once daily after an additional week.

Notify your pharmacist about interactions. For instance, levels of gepirone ER may be increased by diltiazem, verapamil, or other meds.

Use labeling to promote proper administration. Patients should take gepirone ER “With food” and “Swallow whole”...for proper absorption.

Dispense a MedGuide to help warn about side effects and other risks (irregular heartbeats, thoughts of suicide, etc).

Review our resource, Choosing and Switching Antidepressants, for more about treatments for depression, side effects, etc.

Key References

  • FDA. Drug Approval Package: Exxua. November 28, 2023. (Accessed April 18, 2024).
  • Qaseem A, Owens DK, Etxeandia-Ikobaltzeta I, et al. Nonpharmacologic and Pharmacologic Treatments of Adults in the Acute Phase of Major Depressive Disorder: A Living Clinical Guideline From the American College of Physicians. Ann Intern Med. 2023 Feb;176(2):239-252.
  • Kovich H, Kim W, Quaste AM. Pharmacologic Treatment of Depression. Am Fam Physician. 2023 Feb;107(2):173-181.
  • Keam SJ. Gepirone Extended-Release: First Approval. Drugs. 2023 Dec;83(18):1723-1728.
Pharmacy Technician's Letter. May 2024, No. 400509

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