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Jun 30, 2020
Trevena Q2 2020 Earnings Report
Trevena announced FDA approval of OLINVYK and provided a business update.
Key Takeaways
Trevena announced FDA approval of OLINVYK for acute pain management and expects product availability in Q4 2020. The company reported $54.8 million in cash and cash equivalents as of June 30, 2020, sufficient to fund operations through year-end 2021.
FDA approved OLINVYK for the management of acute pain.
OLINVYK product availability is expected in the fourth quarter of 2020.
Company is funded through year-end 2021, including OLINVYK commercialization.
Cash and cash equivalents were $54.8 million as of June 30, 2020.
Trevena
Trevena
Forward Guidance
Trevena expects to make OLINVYK available in the fourth quarter of 2020 following scheduling by the DEA, which may take up to 90 days. The Company expects $54.8 million in cash and cash equivalents will be sufficient to fund operating expenses, including the commercialization of OLINVYK, through year-end 2021.
Positive Outlook
- OLINVYK is expected to be available in Q4 2020.
- FDA approved OLINVYK for acute pain management.
- OLINVYK 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.
- OLINVYK requires no dosage adjustments in patients with renal impairment.
Challenges Ahead
- OLINVYK will not be available for distribution until the United States Drug Enforcement Administration assigns it to its schedule of controlled substances.
- The cumulative total daily dose should not exceed 27 mg, as total daily doses greater than 27 mg may increase the risk for QTc interval prolongation.
- OLINVYK exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.
- Serious, life-threatening, or fatal respiratory depression may occur with use of OLINVYK.
- Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.