Trevena TRVN Stock News

Trevena Inc (NASDAQ: TRVN) is making a run for the top in the market this morning, trading on gains of more than 40%. The gains come after the company announced that it has received approval for a pain treatment from the FDA. Here’s what’s going on:

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TRVN Stock Is Climbing On FDA Approval

In the press release, Trevena said that the FDA has approved OLINVYK. The treatment has been approved for adult patiemtns dealing with acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments simply don’t work.

As a result of the FDA approval, TRVN said that OLINVYK will be commercially available as soon as the DEA issues its controlled substance schedule. It is expected that this release will take place within the next 90 days.

In the release, the company reminded investors that the treatment is an opioid agonist that is the first new chemical entity in this IV drug class in decades. The company said that the treatment offers a differentiated profile that addresses a significant unmet need in the acute pain space.

Importantly, the treatment has a rapid onset of jsut two to five minutes. Moreover, it requires no dose adjustments in patients with renal impairment.

In a statement, Carrie L. Bourdow, President and CEO at TRVN, had the following to offer:

The approval of OLINVYK marks an exciting step forward in Trevena’s mission of translating cutting-edge scientific discovery into therapeutic benefit for patients in need. I would like to thank all of the patients, investigators, and our employees who helped us achieve this important milestone. We will work quickly to bring this novel IV analgesic to patients and healthcare providers in need of alternative treatment options.

The above statement was followed up by Gregory Hammer, M.D., Professor of Anesthesiology, Perioperative and Pain Medicine, and of Pediatrics at Stanford University. Here’s what he had to offer:

Complex patients present unique challenges in the management of their postoperative acute pain, due to the presence of medical comorbidities that can complicate dosing,” said Gregory Hammer, M.D., Professor of Anesthesiology, Perioperative and Pain Medicine, and of Pediatrics at Stanford University. OLINVYK represents a new alternative for clinicians, due to its rapid onset of action, effective pain relief, and unique profile.

This News Is Huge

The fact that Trevena has won an FDA approval alone is great news. However, this particular approval represents a massive win and massive opportunity for the company and its investors.

According to the press release, about 45 million hospitalized patients in the United States receive an IV opioid to treat acute pain. Unfortunately, many of these patients are complex and difficult to treat, including elderly, obese, or renally-impaired patients.

Unfortunately, the numbers of these complex patients are growing. Nonetheless, this new pain management option will fill a massive gap, offering an incredible revenue opportunity and setting the foundation for strong growth in TRVN stock ahead.

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