|6 Months Ended|
Jun. 30, 2020
11. Subsequent Events
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.
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.
The entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef