ANI Pharmaceuticals this week announced Food and Drug Administration approval to produce a delayed-release form of naproxen, the main ingredient in Aleve pain reliever.
ANI Pharmaceuticals secures FDA approval, launches delayed-release naproxen
The firm, based in Baudette, said the generic drug can treat pain, inflammation and arthritis.
The Minnesota Star Tribune
July 3, 2024 at 9:08PM
Naproxen treats moderate pain and inflammation and can be a treatment for arthritis.
“ANI remains committed to driving growth through superior new product launch execution, in keeping with our purpose of ‘Serving Patients, Improving Lives,’” said Nikhil Lalwani, CEO of ANI, in a statement.
ANI’s delayed-release naproxen is a generic version of EC-Naprosyn brand, which UK-based Pharmanovia produces. An ANI representative did not provide additional information about the company’s new drug.
Delayed-release drugs stay in the bloodstream longer, which means patients can take fewer doses, said Tim Gallagher, director of retail and specialty pharmacy for Minneapolis-based Allina Health.
“People much prefer to take fewer tablets or capsules,” Gallagher said.
The strength of the ANI delayed-release tablets, 375 milligrams and 500 milligrams, requires a prescription, Gallagher said.
Naproxen overall remains a common medication. Gallagher said other companies offer a delayed-release version of the drug.
“Naproxen is still used quite a bit. You can buy it over the counter,” Gallagher said.
There are several over-the-counter options similar to the pain reliever/fever reducer medication, such as Aleve, described as naproxen sodium tablets. Aleve’s recommended dosage is every 12 hours.
According to ClinCalc.com, naproxen was the 93rd most-prescribed medication in the U.S. in 2021 with 7.6 million prescriptions.
Last week, ANI announced a deal to buy Georgia-based Alimera Sciences for $381 million. Alimera makes two drugs for specific eye conditions. ANI said the acquisition would boost its rare-disease business.
ANI’s stock closed down 2.9% on Wednesday.
ANI has three manufacturing facilities: two in Baudette and one in East Windsor, N.J.
The company continues to post growth. ANI has projected that the company will have revenue of $520 million to $542 million this year. That would translate into sales gains in the range of 7% to 11%.
Correction: A previous version of this story inaccurately portrayed how delayed-release drugs work and the availability of naprosyn. Delayed-release medications stay in the bloodstream longer, and naproxen sodium, a drug similar to naprosyn found in Aleve, is available over the counter.
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