The next-generation compound of atropine does not contain preservatives or boric acid and can be stored at room temperature for up to 180 days.
On February 15, Harrow announced the launch of its next-generation compounded atropine formulations, which do not contain preservatives or boric acid. Additionally, the new formulations have a physiologic pH of 5.5 and may be stored at room temperature for up to 180 days. The patent-pending formulations are now available through ImprimisRx, Harrow’s wholly owned compounding and mail order pharmacy subsidiary.
“Our mission has always been to help our eyecare professionals address their patients’ unmet needs and to make ophthalmic medications both accessible and affordable,” Mark L. Baum, Chairman and CEO of Harrow, said in a press release. “The availability of these innovative compounded atropine formulations is in keeping with our mission. We believe ophthalmologists, optometrists, and the millions of Americans who may benefit from topical atropine therapy, will appreciate the tremendous value these patent-pending formulations offer.”
Compounded formulations are not reviewed by the FDA for safety and efficacy, but they may be appropriate for patients with clinical needs that are unmet by drugs that have been approved by the FDA. The atropine formulation from ImprimisRx underwent validated analytical tests to ensure consistency, potency, and stability of the compound, though it is not FDA-approved.
The compounded atropine formulation has a pH of 5.5, and can be stored at room temperature for up to 180 days. Additionally, the drug does not contain preservatives or boric acid.
ImprimisRx underscores in a press release that it does not compound copies of commercially available products.
The prescribing information for the compounded atropine formulation can be found here.