Provectus Tries To Put A Positive Spin On PV-10 “Breakthrough” Denial
FDA letter rejecting “breakthrough therapy” status for investigational melanoma treatment is released by the company in an apparent bid to rally support for the drug. The strategy had the opposite effect, however, causing Provectus’ stock to plummet and demonstrating the perils of breakthrough-related disclosures.
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With FDA prohibited from disclosing information about products in development, sponsors must decide whether to announce if the agency has granted or denied a designation request. Communications are particularly challenging for small companies, for whom a denial might be a material event.
Advisory committee votes 24-2 against approval of Intellipharmaceutics’ Aximris XR due to concerns the extended-release oxycodone formulation may be more susceptible to intranasal abuse than existing products; Esteve fares better with its tramadol/celecoxib combination, securing a tie vote on approval for acute pain.
Although abuse by intravenous route is expected to be deterred compared to immediate-release oxycodone, neither nasal nor oral abuse deterrence was demonstrated in two new human abuse potential studies, agency concludes; product has a new formulation and a new name, Aximris XR, since a 2017 AdComm.