The New Jersey-based drug firm said when taken with a high fat meal SequestOx had an average Tmax – the length of time the drug is present at its maximum concentration in the bloodstream – of 4.6 hours, The comparator product, Roxicodone, has a Tmax 3.4 hours.
Elite said it will “not proceed with the rest of the clinical trials, and seek clarity from FDA before deciding on the next steps for immediate release SequestOx.”
CEO Nasrat Hakim said: “We were hoping for better and more decisive results for the reformulated immediate release version of SequestOx."
Elite began trialling the reformulated version of SequestOx in March. The aim was to address US Food and Drug Administration (FDA) concerns that earned the original formulation a complete response letter in 2016.
The CRL has not been made public.
However, according to an Elite US Securities and Exchange Commission (SEC) filing at the time, the US regulator refused to approve SequestOx on the basis that there was a risk of overdose in patients who have eaten a high fat meal.
Elite met with the FDA to discuss the CRL in December, describing the talks as positive.
Two months later during Elite’s fiscal Q3 earnings call in February, Hakim said the firm had tweaked the SequestOx formulation to try and address the issues raised by the agency.
SequestOx is based on the ART formulation platform, in which particles containing the drug active are encapsulated with particles containing the opioid antagonist naltrexone.
The idea, according to Elite, is that when the drug is taken as intended the oxycodone is delivered and the naltrexone passes through the body unreleased. However, if the capsule is crushed the antagonist is released, blocking the effects of the opioid.
Elite said it will continue to develop products that use the ART technology. This includes a generic version of Oxycontin (extended release oxycodone hydrochloride), for which the firm plans to submit an Abbreviated New Drug Application (ANDA) this year.