GlaxoSmithKline, Alcon Switch 3 Meds To OTC In Play For Big Volume

Drugmakers usually target two things: pricing and volume, hopefully both at the same time. But when prices go down, volume’s the thing, and GSK and Alcon have pulled off prescription-to-OTC switches in hopes of giving aging brands a boost.

GlaxoSmithKline’s Voltaren Arthritis Pain gel and two Alcon eye drops, Pataday and Patanol, will now be sold over the counter after the FDA approved switching the drugs from prescription-only status on Friday.

Moving into OTC sales will give the three drugs greater consumer access at a likely much lower price point, the agency said in a release.

To pass muster for the switch, both GSK and Alcon were required to provide data showing that consumers could dose themselves safety and effectively, the FDA said. The drugmakers were also required to show that patients can understand how to use the drug without a healthcare professional’s supervision.

Voltaren gel notched its first FDA approval in 2007 to treat osteoarthritis joint pain responsive to topical treatment. The two Alcon medications, Pataday Twice Daily Relief and Pataday Once Daily Relief, were approved in 1996 and 2004, respectively. The twice-daily formulation was approved under the name Patanol to treat the symptoms of allergic conjunctivitis.

The drugmakers’ volume play will also likely lower the cost of all three medications at a time when drug pricing has become a hot-button concern for the industry, regulators and Capitol Hill.

In January, a GlobalData survey found that drug pricing and reimbursement remain the industry’s top concern for 2020. In the survey, 49% of respondents said pricing and reimbursement is their top worry for the year. Behind drug pricing, 14% of respondents said they’re concerned about the U.S. political divide, while other threats included Amazon and biologics patent expirations.

It’s “not surprising” pricing remains the top concern, GlobalData’s pharma head Bonnie Bain, Ph.D., said in a statement, “especially since 2020 kicked off with drug companies in the U.S. again raising prices for several hundred drugs.”

This year’s price hikes are expected to average 5%, compared with 6.3% last year, she said. And while lawmakers talk up their ambitions for lowering costs, Bain said she believes “additional efforts to lower prices will likely stall for now due to the looming impeachment trial for President Trump.-Fierce Pharma