Tiny Trevena may have a new lease on life for its controversial opioid painkiller — rejected by the FDA last November citing the dearth of drug safety data — following a scathing internal staff critique and lopsided expert panel review.
The company’s shares $TRVN swelled nearly 120% on Monday after Trevena said the agency had agreed that the drug’s existing safety database would suffice for a particular dose of the drug — helping forge a path forward for the biotech to resubmit its marketing application.
The IV injection, oliceridine, was developed to help adult patients manage moderate to severe acute pain. It is designed to induce a similar analgesic effect as morphine, but work faster and reduce the messy side effects of sedation, respiratory depression and slowing gastrointestinal motility. But mixed trial results and gaps in safety data including QT interval data — the time the heart muscle takes to recharge between beats — prompted the regulator to eventually reject the opioid in early November. At the time, the agency asked for a bigger safety database for the drug, as well as “certain additional nonclinical data and validation reports”.
On Monday, Trevena said its current safety data would support labeling at a maximum daily dose of 27 mg, and that the FDA had agreed that the company conduct a study (including placebo- and positive-control arms) in healthy volunteers to amass the requested QT interval data.
The Chesterbrook, Pennsylvania-based drug developer intends to submit a protocol and analysis plan to the FDA shortly and, upon receipt of regulatory feedback, expects to initiate the study in the first half of 2019. The company added it does not need any more efficacy data to resubmit its marketing application for the drug, but did not provide any details on when that resubmission could be expected.
CEO Carrie Bourdow said she was “encouraged by the productive discussion” with the FDA in a statement.
Back in 2016, under the behest of CEO Maxine Gowen, Trevena had suggested an end-of-Phase II meeting with the FDA had culminated in a general agreement about the Phase III design for oliceridine, and that Gowen was “very pleased” with the discussion. But it was only last year that it was revealed that the FDA had in fact indicated otherwise — the agency had disagreed with proposed dosing and the primary endpoint in the late-stage program. This revelation prompted attorneys at Bernstein Liebhard to accuse Trevena execs, particularly former CEO Maxine Gowen, of misleading investors for roughly two years.
FDA policy dictates it must not release any information related to discussions with drug sponsors until a drug is up for review. Commissioner Scott Gottlieb had initially made promises to arm the agency to reveal more information, for instance the regulator’s reasoning behind issued CRLs, but that has not come to fruition.
Meanwhile, the FDA’s approval of another opioid amidst a national crisis of opioid abuse, misuse and addiction that kills about 130 Americans each day will likely cause more friction. AcelRx’s $ACRX approval for its opioid Dsuvia last year sparked a flurry of intense criticism, even prompting a member of the FDA’s own expert panel to call out the agency’s attitude toward opioids as “willful blindness that borders on the criminal.“
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