FDA Approvals Roundup: Eprontia, Dyanavel

RoundupsRoundups | 10 November 2021 |  By 

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New approvals
Eprontia okayed as liquid form for treating epilepsy and migraine
Azurity’s Eprontia (topiramate) oral solution has been approved for treating seizures and migraines. The approval covers use of the anticonvulsant as a monotherapy and adjunctive therapy for seizures in patients aged 2 years or older and as a preventive treatment for migraine in patients aged 12 years or older.
The new oral formulation of topiramate was approved on the strength of studies showing that the relative bioavailability of Eprontia was similar to that of topiramate sprinkle capsules, which themselves are comparable in bioavailability to topiramate tablets.
Dyanavel okayed as extended-release tablets for ADHD
Tris Pharma’s Dyanavel XR (amphetamine) has been approved in extended-release tablet form for treating attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years and older.
Approval for the tablet form of the central nervous system stimulant was based on findings in a clinical study in 32 healthy adults showing bioequivalency with Dyanavel XR extended-release oral suspension, which was approved for the same indication in 2015. Efficacy of the oral suspension had been demonstrated in a Phase 3 laboratory classroom study of 108 children aged 6 to12 years with ADHD. Within an hour of once-daily oral dosing, the children experienced symptom improvement  that lasted more than 13 hours.
In a separate double-blind, placebo-controlled, fixed-dose Phase 3 study in adults with ADHD, patients receiving Dyanavel XR tablets showed significant improvement in mean scores for a skill-adjusted math test across all post-dose time points up to 14 hours after dosing.
Dyanavel XR is a Schedule II, federally controlled substance. It carries a boxed warning for abuse and dependence.



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Tags: FDA, US

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