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  • Looking Back at the First Retinoid Rx-to-OTC Switch

    Topical retinoids have a vital role in addressing the development and maintenance of acne; they are alternative first-line therapies for comedonal, mild, and moderate inflammatory acne, as well as maintenance to keep acne in remission. In 2016, the FDA approved switching Differin Gel 0.1% (adapalene) from prescription-only to over-the-counter (OTC) status for use in people 12 years of age and older, and it was a landmark event. Differin Gel 0.1% is the first and only OTC product containing a full prescription-strength retinoid. It was the first new, FDA-approved active ingredient to be introduced to the OTC acne category in over 30 years.

    The approval of OTC Differin stemmed from studies which showed that consumers could understand information on the OTC label, appropriately select whether the product was right for them, and use the product correctly. Prescriber guidance is not necessary for proper OTC use of Differin. Safety of the OTC use of Differin was also assessed and confirmed in a maximal use trial. This evaluated the absorption of the drug through acne-affected skin when applied daily or over a large surface area (face, shoulders, upper back, and chest) and demonstrated that absorption is limited, therefore limiting the risk of teratogenicity. Women who are pregnant, planning to become pregnant or are breastfeeding should still consult their healthcare provider before use.

    Differin Gel 0.1% originally was approved in 1996 as a prescription product. The switch to OTC status was significant to patients in many ways, including potentially significant cost savings. Although a generic version of Differin was approved in July 2010, its cost is still relatively high. A 45g tube of brand-name Differin Gel 0.1% is approximately $600, while prescription-only generic adapalene 0.1% gel is around $160 per 45g tube. Some pharmacy benefit managers still choose to list these as nonpreferred items, resulting in high copays. The OTC Differin 0.1% gel 45g tube ranges from $25-$30. The availability of OTC Differin could save patients hundreds of dollars per year and offers convenience and cost savings from dermatologist visits.

    This transition has been particularly important for pharmacists. When they identify patients who may benefit from OTC topical retinoid therapy, pharmacists need to be prepared to counsel them properly. Topical retinoids are recommended as both monotherapy for acne and in combination with oral antibiotics in patients with inflammatory acne or a combination of the different types of acne. Common adverse reactions may include erythema, scaling, dryness, pruritus, burning/stinging and photosensitivity. Although prescription-only Differin dosage forms also include cream, lotion, and 0.3% gel, only the 0.1% gel has been made available OTC.

    Stay informed about drug information, including Differin Gel 0.1% OTC, by updating or registering your profile to receive email alerts and other critical drug information updates from PDR. You can also stay current by using the official PDR app, available now for free from your favorite app stores.


    Adapalene topical Prices, Coupons and Patient Assistance Programs. Drugs.com website. https://www.drugs.com/price-guide/adapalene-topical#topical-cream-0-1. Accessed November 15, 2017.

    Differin (adapalene) gel label. FDA website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021753s004lbl.pdf. Updated February 2012. Accessed November 30, 2017.

    Differin frequently asked questions. Differin website. https://www.differin.com/learn/faqs. Accessed December 6, 2017.

    Differin Prices, Coupons & Patient Assistance Programs. Drugs.com website. https://www.drugs.com/price-guide/differin. Accessed November 15, 2017.

    FDA approves Differin Gel 0.1% for over-the-counter use to treat acne. FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm510362.htm. Updated July 8, 2016. Accessed November 30, 2017.

    Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol 2016;74(5):945-975. http://www.jaad.org/article/S0190-9622(15)02614-6/pdf.