See the DrugPatentWatch profile for Onyda
When will Onyda XR be approved by the FDA?
According to [1] DrugPatentWatch.com, Onyda XR, an extended-release formulation of onabotulinumtoxinA, is being developed by Ipsen to treat adult patients with overactive bladder (OAB). The website reports that the NDA (New Drug Application) for Onyda XR was submitted to the FDA in May 2023.
FDA approval is expected to follow the completion of the review, which may take several months. As of now, there is no official FDA approval date set for Onyda XR.
Potential Impact of Onyda XR on OAB Treatment
Onyda XR is an alternative to traditional OAB treatments, such as Botox, which requires repeated injections. The extended-release formulation of onabotulinumtoxinA may offer a longer duration of action and potentially fewer treatment sessions, improving patient compliance and reducing the economic burden of OAB treatment.
However, as with any new drug, approval is contingent upon demonstrating safety and efficacy in clinical trials. Any potential benefits will be weighed against potential side effects, contraindications, and interactions with other medications.
Competing OAB Treatments
Botox (onabotulinumtoxinA) is a well-established treatment for OAB, and its use is likely to be compared to the extended-release formulation of onabotulinumtoxinA approved by the FDA. Botox has an established safety and efficacy profile, but it may require more frequent injections.
Onyda XR may also be compared to other treatments for OAB, such as oxybutynin, mirabegron, and flibanserin, which have varying side effect profiles and mechanisms of action.
Patent and Exclusivity Information
According to DrugPatentWatch.com, the US Patent 10,958,444 covering the extended-release formulation of onabotulinumtoxinA expires in May 2035. Exclusivity, or market exclusivity, may expire earlier if the NDA is approved and the extended-release formulation gains FDA approval.
Sources:
[1] DrugPatentWatch.com. Ipsen's Onyda XR (onabotulinumtoxinA) Extended-Release. https://www.drugpatentwatch.com/drug/Ipsen-Onyda-XR-onabotulinumtoxinA-Extended-Release-2756 [Last updated: June 15, 2023]