After a unanimous vote by its Nonprescription Drugs Advisory Committee on April 15, 2016,1 the FDA approved switching Differin gel 0.1% from prescription-only to OTC status. Although this announcement wasn’t followed by an expected release date for the OTC version, the brand’s website has been updated to display a “coming to a store near you” message.
Originally approved in 1996 for children and adolescents 12 years and older, adapalene (Differin) has become a popular topical treatment option for acne.2 After-market data shows the drug’s effective in those younger those 12 years without increased risk of adverse effects, but it’s unclear whether the product will be labeled for OTC use in this age group.3
Already approved for OTC use in Russia, Differin will be the first retinoid to appear in OTC aisles in the United States. Although prescription-only Differin dosage forms also include cream, lotion, and 0.3% gel, only the 0.1% gel is being made available OTC at this time.2
Retinoids are vitamin A derivatives that control cellular changes in the skin, overgrowth of keratin cells, and inflammation in skin cells, which block pores and cause acne. Retinoids, including adapalene, are available as single-agent and combination products. These agents’ current places in therapy are as alternative first-line therapies for comedonal (involving whiteheads and blackheads), mild, and moderate inflammatory acne, as well as maintenance use to keep acne in remission. 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.3
Although a generic version of prescription adapalene was approved in July 2010, its cost to the patient is still relatively high.4 The average price for a 45-g tube of brand-name, prescription-only Differin gel 0.1% could cost up to $300, while the prescription-only generic adapalene 0.1% gel may cost around $150.5,6 Additionally, some pharmacy benefit managers still choose to list these as nonpreferred items, resulting in high co-pays for patients. Therefore, the product’s switch to OTC status alone could save patients hundreds of dollars per year, not to mention added convenience and cost savings from not having to visit a dermatologist for a prescription.
This prescription-to-OTC switch is the first to occur in the acne treatment space in the last 30 years. The FDA’s decision to transition Differin to OTC status stemmed from reviewing results from a label comprehension study, self-selection study, and actual-use trial, all conducted over the 20-year period since the product’s first approval. Collectively, these studies showed patients could understand labeling information and properly use Differin without prescriber intervention.
It will now fall on the pharmacist to correctly identify patients who may benefit from OTC topical retinoid therapy and counsel them on proper use.
- FDA Advisory Panel Backs OTC Adapalene Gel 0.1% for Acne. Medscape. medscape.com/viewarticle/862113. Accessed July 28, 2016.
- Facts & Comparisons eAnswers – ADAPALENE. online.factsandcomparisons.com.libproxy.siue.edu/MonoDisp.aspx?monoID=fandc-hcp12477&quick=165479%7c5&search=165479%7c5&isstemmed=True&NDCmapping=-1&fromTop=true#firstMatch. Accessed July 28, 2016.
- Zaenglein AL, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016 May;74(5):945-973.e33.
- FDA Approves First Generic Adapalene 0.1% Cream. Medscape. medscape.com/viewarticle/724781. Accessed July 28, 2016.
- Differin Prices, Coupons & Patient Assistance Programs. Drugs.com. drugs.com/price-guide/differin. Accessed July 28, 2016.
- Adapalene topical Prices, Coupons & Patient Assistance Programs. Drugs.com. drugs.com/price-guide/adapalene-topical#topical-cream-0-1. Accessed July 28, 2016.
Miranda Wilhelm, PharmD
Miranda Wilhelm, PharmD, is a Clinical Associate Professor at Southern Illinois University Edwardsville (SIUE) School of Pharmacy and a Clinical Community Pharmacist with Schnucks Pharmacy. Dr. Wilhelm received her PharmD from the University of Kansas School of Pharmacy.