Jiangsu Nhwa Pharmaceutical Co., Ltd. (SHE: 002262), a China-based pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its Olinvyk (oliceridine; TRV130) injection. The approved indication is for adult patients requiring management of acute pain severe enough to necessitate an intravenous opioid analgesic, where alternative treatments have proven inadequate.
Olinvyk’s Development and Commercial Rights Acquired by Nhwa
Olinvyk was originally discovered by US-based Trevena Inc., (Nasdaq: TRVN). Nhwa acquired the development and commercial rights to the drug in China through a licensing deal in 2018. The approval filing was supported by data from two bridging trials conducted in China and also utilized US clinical data from Trevena.
Financial Implications and Milestone Payments
This week’s market approval triggers a USD 3 million milestone payment to Trevena from Nhwa. Additionally, Trevena is set to receive a further USD 15 million upon the first commercial sale of the drug and another potential USD 10 million payout if certain sales milestones are achieved. Nhwa has previously paid over USD 11 million in upfront and two milestone payments to Trevena.
Olinvyk’s Unique Mechanism and Advantages
Olinvyk is a first-in-class G-protein biased µ-opioid receptor agonist, offering similar efficacy to morphine but with significantly reduced beta-arrestin 2 recruitment and receptor internalization. This results in fewer adverse effects, including respiratory depression and constipation. Trevena received approval for Olinvyk in the US in 2020, where it is available in 1 mg/1 mL and 2 mg/2 mL single-dose vials, and a 30 mg/30 mL single-patient-use vial for patient-controlled analgesia (PCA). Approved PCA doses are 0.35 mg and 0.5 mg, with doses greater than 3 mg not to be administered.-Fineline Info & Tech
