Trevena's Pain Drug Wins Breakthrough Tag from the FDA
February 22, 2016
By Mark Terry, BioSpace.com Breaking News Staff
King of Prussia, Pa.-based Trevena (TRVN) Trevena said today that the U.S. Food and Drug Administration (FDA) has given the company’s TRV130 (intravenous oliceridine) Breakthrough Therapy designation. The drug is currently in Phase III trials for the management of moderate-to-severe acute pain.
TRV130 optimizes µ opioid receptors, and is the first µ opioid G protein selective modulator (µGPS). In Phase II trials, the drug was a rapid and powerful pain killer with fewer adverse effects than opioids.
“We are delighted that the FDA has chosen to grant Breakthrough Therapy designation to oliceridine,” said Maxine Gowen, Trevena’s chief executive officer, in a statement. “There is an urgent need for a novel analgesic that delivers powerful pain relief with improved safety and tolerability. We believe this designation recognizes our promising Phase II study data for oliceridine, which showed encouraging differentiation from morphine. We look forward to working even more closely with the FDA to facilitate our development of oliceridine.”
The company’s Phase III trial, dubbed ATHENA-1, is an open label, multicenter study designed to evaluate the drug’s safety and tolerability in about 900 patients. Patients enrolled suffer from moderate-to- severe pain as the result of medical conditions or surgery.
The company is also scheduled for an End-of-Phase II meeting with the FDA at the end of the first quarter. Trevena also expects to announce details of its Phase III program in the second quarter.
On Dec. 16, 2015, Trevena was selected to be listed in the NASDAQ Biotechnology Index.
Trevena’s appears to be recovering after a downturn. Shares traded at $13.30 on Sept. 18, 2015, dropped to $9.62 on Oct. 30, and then rose back to $12.92 on Nov. 27. Shares fell to $6.69 on Jan. 28, 2016 and are currently trading for $9.58.
On Feb. 19, The The Vista Voice reported that Trevena had an average “buy” rating from nine research firms. Eight gave it a “buy” and one gave it a “hold.” The average one-year price target was $15.80.
On Dec. 10, David Soergel, the company’s chief marketing officer, sold 27,217 shares of company stock for an average price of $10.55 or a total value of $287,139.35. Jennison Associates, an institutional investor, also recently bought a new position in Trevena when it acquired 700,000 shares in the third quarter, valued at approximately $7,245,000, which came to ownership of 1.38 percent of Trevena.
Oliceridine, because it is administered intravenously, is aimed at hospitalized patients. Its mechanism of action is similar to morphine and fentanyl, but is designed to avoid pathways associated with respiratory problems and gastrointestinal side effects like constipation.