- The Food and Drug Administration has knocked back a New Drug Application for an abuse-deterrent formulation of oxycodone developed by Mallinckrodt's specialty generics subsidiary, SpecGx, issuing the company a Complete Response Letter.
- While it's not clear exactly what additional info will be required, the FDA suggested areas of "further evaluation necessary to resubmit," according to a Wednesday statement from Mallinckrodt. SpecGx will request a meeting with the U.S. regulatory agency.
- The drug candidate, a reformulation of Roxicodone, was designed as an immediate-release opioid for severe pain with reduced risk of intravenous and intranasal abuse.
The CRL for reformulated Roxicodone (oxycodone) isn't entirely surprising, after a fairly close 10-7 vote recommending approval from an FDA joint advisory committee. The committee was split on how the drug should be labeled, voting in favor of labeling the drug as abuse-deterrent for nasal abuse but against it on intravenous abuse potential.
While Mallinckrodt supplied few details about the CRL, the FDA's decision could also hint at concerns over appropriate labeling for abuse-deterrent opioids amid an overdose epidemic.
Mallinckrodt spent 2017 in an effort to rebuild its pipeline and move away from controversy, including from investigations into opioid drug marketing and from litigation over sharp increases in the price of H.P. Acthar Gel (repository corticotropin injection). Price increases began before Mallinckrodt acquired the drug in its buyout of Questcor, but have continued under Mallinckrodt's leadership.
2018 hasn't been easy, either. In August the company received a CRL for stannsoporfin, which was under review for use in babies born at 35 weeks of gestation or more and who are at risk of developing severe jaundice.
And just last month, puzzling results from Mallinckrodt's rare disease drug VTS-270 raised questions about a drug the company acquired in a $1.2 billion deal with Sucampo.
Restructuring is on the agenda, too.
Earlier this month, Mallinckrodt announced a plan to spin off its specialty generics business and create two independent and publicly traded companies. One, a specialty generics company based in St Louis, would take Mallinckrodt's name and stock ticker, as well as its opioid lawsuits.
The other would take a new name, and the branded products that make up 70% of the company's sales, including top seller H.P. Acthar Gel — a potential new start for the company after several years of headaches.