Quarterly report pursuant to Section 13 or 15(d)

Subsequent Events

v3.20.2
Subsequent Events
6 Months Ended
Jun. 30, 2020
Subsequent Events  
Subsequent Events

11. Subsequent Events

OLINVYK Approval

On August 7, 2020, the Company announced that the FDA approved OLINVYK in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK is a new chemical entity and offers a differentiated profile that addresses a significant unmet need in the acute pain management landscape. OLINVYK delivers IV opioid efficacy with a rapid 2-5 minute onset of action. In addition, OLINVYK requires no dosage adjustments in patients with renal impairment, a large patient population with significant medical complications. The Company expects to make OLINVYK available in the fourth quarter of 2020 following scheduling by the U.S. Drug Enforcement Administration, which may take up to 90 days from the date of FDA approval.

Upon FDA approval of OLINVYK, a $3.0 million milestone, subject to Chinese withholding tax, became payable to the Company by its licensee in China, Jiangsu Nhwa Pharmaceutical Co. Ltd.

TRV250 Trial

On August 10, 2020, the Company terminated its proof-of-concept study for TRV250 for the treatment of acute migraine. The study protocol had required subjects to be monitored in an in-patient setting for 24 hours, and due to the global COVID-19 pandemic, enrolment had been paused since March 2020. The Company continues to investigate alternative development plans for TRV250 and its delta-opioid receptor, or DOR, agonist program and expects to re-initiate clinical studies in the second half of 2021.