This quarterly review on New Drug Applications contain data for applications approved for the first time during the first quarter of 2019, which includes New Molecular Entities (NMEs) and new biologics. A total of 29 applications were approved by FDA during these three months.
Following are the percentages of various dosage form classifications in this quarter- 27.6% tablets, 6.9% capsules, 24.1% injectables, 13.8% solutions, 3.5% powders, and 24.1% miscellaneous. Miscellaneous dosage forms include gel, ointment and other unknown dosage forms and route of administrations as they are tentatively approved under 505(b)(2) application.
GLOPERBA by ROMEG Therapeutics, is the first liquid formulation of colchicine approved by the FDA for the prophylaxis of gout flares. Existing therapies (capsule and tablet formulations) do not adequately address the physician’s need to adjust the dose to control drug interactions or health conditions such as when patients are undergoing kidney dialysis. GLOPERBA oral solution will now allow physicians to make dosage adjustments for their patients but also beneficial for patients who can’t swallow solid doses or pills.
In March, the U.S. Food and Drug Administration (FDA) approved Sunosi (solriamfetol) to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). It is the first dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) approved to treat excessive daytime sleepiness in adults living with narcolepsy or OSA.
The FDA's approval of Sunosi is based on data from the Treatment of Obstructive sleep apnea and Narcolepsy Excessive Sleepiness (TONES) Phase 3 clinical program. Sunosi was evaluated in more than 900 adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea and was shown to maintain its effect relative to placebo after six months of use.
In the same month, FDA also approved Rocklatan to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Rocklatan is a once-daily fixed dose combination of Latanoprost and Netarsudil in the form of an eye drop. Combining the most widely prescribed prostaglandin analog (PGA), Latanoprost and a first-in-class Rho kinase inhibitor, Netarsudil in one dosage form, Rocklatan is specifically designed to target the trabecular meshwork of eye. The diseased trabecular meshwork is considered to be the main cause of elevated IOP in open-angle glaucoma and ocular hypertension.