New FDA Approvals

Switch Activity Heating Up with New OTC Approvals

The U.S. FDA announced approval of three Rx-to-OTC switches on February 14, 2020. One is GlaxoSmithKline’s OTC version of its topical nonsteroidal anti-inflammatory (NSAID) pain reliever, Voltaren Gel (diclofenac sodium topical gel, 1%). This OTC medication will be indicated for temporary relief of joint pain and stiffness due to the most common type of arthritis, osteoarthritis, which increases with age, affects millions of people in the U.S., and can generally be self-diagnosed. Arthritis is the swelling and tenderness of one or more of the joints. Symptoms of arthritis include pain, swelling, stiffness, and difficulty moving a joint. This medication has been sold without a prescription safely for years in Europe and marks the first topical analgesic with anti-inflammatory properties available without a prescription in the United States. It also offers another non-opiate option for those suffering from chronic arthritis pain.   

On the same day, the FDA also announced the approval of the Rx-to-OTC switch of Alcon’s Pataday Once Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.2%) and Pataday Twice Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.1%) eye drops, indicated for ocular allergies due to environmental allergens. These drugs were previously sold as prescription drugs for allergic conjunctivitis. The OTC approval includes indications for the temporary relief of itchy and red eyes due to pollen, ragweed, grass, animal hair, or dander. 

In May 2018, the FDA approved the switch of Valeant/Bausch & Lomb’s Lumify eye redness remover for OTC sale. Lumify (brimonidine tartrate ophthalmic solution 0.025%) is the first OTC eye drop developed with low-dose brimonidine tartrate for the treatment of eye redness, which relieves eye irritation and redness within a minute and lasts up to eight hours.   

These switched medications offer consumers new alternatives in the eye care and topical analgesics categories and will help the overall OTC market grow after it has struggled to realize gains over the past several years, with overall sales growth stagnating around 2.0%. Traditionally, strong gains have been realized as a result of switches, but until these latest switches were approved, there had not been many recently approved in the United States. The last major Rx-to-OTC switches that were approved were Xyzal (Sanofi) and Flonase Sensimist (GSK) for allergies in 2017.   

However, there appears to be a new crop of drugs that are candidates to switch in the near future in categories such as oral contraceptives, erectile dysfunction, smoking cessation, and sleeping aids.  Kline’s Rx-to-OTC Switch Forecasts study will provide a comprehensive, objective assessment of the Rx-to-OTC switch landscape including forecasts of switches in the United States in existing OTC categories and projections for new OTC categories. The study provides a broad assessment of “switchable” OTC categories, a specific analysis and forecasts for the most-likely switch categories and drugs, and an analysis of regulatory and retail paradigm shifts and implications for future switches. In addition to a detailed written report, this service provides Kline’s interactive and proprietary FutureView Forecasting Model to help users predict sales of new switches. For more details, contact us.   

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