The US Food and Drug Administration (FDA) puts the needle in the arm of drug company Trevena (TRVN). The agency’s critical briefing documents for Thursday’s adcom meeting state that the company’s pain drug oliceridine could lead to more opioid abuse than pain relief. The documents also showed that oliceridine-treated mice had a similar reaction to the medication as mice on morphine and were also negatively affected in other parts of the body.
Oliceridine is a G protein-biased ligand at the mu-opioid receptor indicated for the management of moderate to severe acute pain in adult patients for whom an intravenous opioid is warranted. In reaction to the safety concerns, TRVN stock fell a whopping 60% in Tuesday’s trading session.
The FDA advisory committee meeting is scheduled for October 11 to discuss the NDA for oliceridine, which has a November 2 PDUFA date.
Page 14 of the report details the challenges the product will face:
“While opioid analgesics remain a necessary medication for the treatment of moderate to severe pain when alternative treatment options are inadequate, their overuse in clinical settings, diversion, and abuse has led to a difficult public health issue – balancing the needs of patients in pain with the public health safety risks. Most opioid overdose deaths in the US occur from illicit heroin, fentanyl, and fentanyl analogs; however, prescription opioid medications are also a major source of morbidity and mortality (CDC 2017). A majority of the prescription opioids misused or abused in the community are oral medications that are dispensed directly to patients (SAMHSA 2017). Thus, there is currently an ongoing effort to reduce the number and size of prescriptions for oral opioid medications.”
The briefing documents lead the Street to believe a “no” vote is line from the FDA. TRVN probably doesn’t think that’s dope. Trevena debuts the product at an ideal time, as the U.S. is dealing with an opioid crisis. 2016 data from the Centers for Disease Control and Prevention states 66% of all drug overdose deaths in the U.S. were from opioids.
The stock is currently selling at around $1.30, reaching a record low for the company. TipRanks has the stock listed with a price target of $10.67. Out of three analysts who provided ratings in the last three months, all three recommending buying. This saga will be worth following as the week unfolds. (See TRVN’s price targets and analyst ratings on TipRanks)