The FDA Just Approved This Acne Drug for OTC


Much has been made of the FDA’s torturous drug approval process. It can take years, even decades, and hundreds of millions of dollars to shepherd a promising new compound through the FDA’s ringer.

If successful, the compound’s owner earns the right to make it available on the prescription market, often for narrowly tailored indications. Patients who stand to benefit from the compound, but who aren’t willing or able to set up a doctor’s appointment (perhaps because they can’t afford to do so), are out of luck.

Opening a New Front in the War on Acne

Maybe the FDA is getting the message. reports that the administration approved a new over-the-counter retinoid drug indicated for mild to moderate acne treatment. It’s Differin Gel 0.1% (adapalene), and it’s the first new compound approved for over-the-counter acne treatment since the 1980s — before many of today’s acne sufferers were even alive.

Young manLongtime acne sufferers know that OTC topical products don’t always do the trick. In fact, some best-selling, top-of-mind products like Proactiv produce surprisingly pedestrian results, according to many reviews and studies.

Differin Gel appears to be different. The drug has been around in prescription form since the mid-1990s, albeit in stronger form. As a retinoid, its active ingredient is chemically similar to Vitamin A, an essential nutrient. It only needs to be applied once per day, regardless of the scope or severity of the user’s condition, and is approved for use in children and adults 12 and older. Over the course of five clinical trials, researchers found little evidence of blood absorption or serious side effects, suggesting a favorable risk-reward profile for over-the-counter use.

Hold the Balloons

Differin Gel 0.1% isn’t a miracle drug. Little research has been done around the compound’s effects on pregnancy, so it’s best for women who are pregnant, nursing, or planning to become pregnant to consult their physicians before beginning over-the-counter treatment.

And, even if it doesn’t have life-threatening side effects, Differin Gel 0.1% is not without downsides. The drug heightens the skin’s sun sensitivity, so users should apply sunscreen daily while taking Differin, especially on days when long-duration sun exposure is expected. Sun sensitivity is particularly problematic for fair-skinned users, for whom Differin-exacerbated sunburns can be severe.

Other side effects include temporary rash or skin irritation at the outset of treatment. These are usually mild and typically resolve within two to four weeks. Longer-duration events should be reported to a medical professional and may be cause for interruption or cessation of treatment.

Solutions for Moderate to Severe Acne

Finally, it’s worth reiterating that Differin Gel 0.1% is not indicated for patients with severe acne. Patients for whom other over-the-counter acne medications are ineffective are unlikely to experience significant improvement with Differin Gel 0.1%. Differin Gel 0.3%, the prescription version of the medication, is indicated for more severe cases.

Of course, Differin isn’t the only acne game in town. Patients who fail to respond well to Differin or experience have plenty of other options to choose from, including hard-hitting prescription compounds indicated for severe acne.


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