Shares of Trevena Inc. (TRVN) soared more than five-fold higher, up 420.6% on active trading Monday after the biopharmaceutical company announced that its China-based partner Jiangsu Nhwa received formal approval from Chinese health regulators for the pain treatment Olinvyk. The Pennsylvania-based firm saw 75.7 million shares change hands, compared with the full-day average over the past 30 days of about 111,100 shares.
Olinvyk, which was approved by the U.S. Food and Drug Administration (FDA) in August 2020, has now received the green light from China’s National Medical Products Administration (NMPA) as a new drug for the short-term management of acute postoperative pain in adults. Chinese approval marks a crucial milestone for Trevena and its efforts to further develop and commercialize Olinvyk globally. Olinvyk is an opioid agonist that is specifically designed to alleviate moderate to severe pain caused by acute surgical procedures.
The Chinese approval came just weeks after Trevena reported positive results from a Phase 2 clinical trial evaluating its experimental migraine treatment, TRV250. This treatment showed promising improvements in headache pain intensity, headache-associated symptoms, and disability caused by migraines. The findings laid the groundwork for an upcoming Phase 3 clinical trial, which will provide further validation for the drug’s safety and efficacy.
Trevena’s newly approved Olinvyk offers several advantages over traditional opioids, such as morphine and hydromorphone, in managing acute postoperative pain. Olinvyk provides rapid onset and effective pain relief without the significant respiratory and gastrointestinal side effects typically associated with conventional opioids. Additionally, Olinvyk is expected to have a lower risk of opioid abuse, addiction, and overdose compared to other pain treatments.
China represents a significant market opportunity for Trevena, as the country experiences rapid growth in surgical procedures, fueled in part by its aging population and expanding healthcare infrastructure. According to a report by Research and Markets, the Chinese surgical procedures market is expected to reach $1.7 billion by 2024, with a compound annual growth rate (CAGR) of 15.8%. The growing need for effective pain management solutions in China presents a strong potential for Olinvyk to succeed commercially.
Furthermore, China’s health regulators have been working to improve the nation’s drug approval process in recent years to foster a more innovative and globally competitive pharmaceutical industry. In 2017, the NMPA implemented a series of regulatory reforms to expedite the review and approval of new drugs, reduce regulatory barriers, and streamline clinical trials. Olinvyk’s approval is an example of this shift towards a more efficient and innovation-friendly regulatory environment in China.
Olinvyk’s approval comes amidst growing global concerns over the opioid epidemic, which has affected millions of people around the world, resulting in high rates of drug addiction, overdose deaths, and significant economic burden. Opioid abuse remains a major public health crisis in the United States, where approximately 50 million people suffer from chronic pain and 20 million individuals are diagnosed with an opioid use disorder. Olinvyk’s potential ability to mitigate these concerns, while providing effective pain relief, positions the drug as a valuable asset in combatting this ongoing crisis.
In addition to Olinvyk, Trevena has a robust pipeline of therapeutics targeting novel, high-value drug markets. These include TRV027 for the treatment of acute respiratory distress syndrome (ARDS) associated with COVID-19, TRV734 for the treatment of opioid use disorder and chronic pain, and TRV250 for migraine treatment. Trevena’s promising drug pipeline, combined with its recent regulatory successes, highlights the company’s strong growth potential in the coming years.
Overall, the approval of Olinvyk in China represents a significant milestone for Trevena, showcasing the company’s ability to navigate complex regulatory processes and bring innovative therapeutics to market. This achievement, alongside the growing demand for pain management solutions in China and the global focus on addressing the opioid epidemic, bodes well for Trevena’s continued success in the pharmaceutical industry.
With the NMPA’s stamp of approval under its belt, Trevena is better positioned to develop and commercialize Olinvyk in key markets around the world. The company’s robust drug pipeline and commitment to addressing high-value therapeutic areas further strengthen its prospect for sustainable growth and profitability. As Trevena continues to advance its clinical programs and forge strategic partnerships, investors have reason to be optimistic about the company’s future prospects.
