CHESTERBROOK, PA — Trevena, Inc. (Nasdaq: TRVN) has provided an update on the U.S. commercial launch for OLINVYK (oliceridine) injection and announced anticipated milestones for 2021.
“We enter 2021 focused on building upon the foundation we laid in 2020 to deliver a successful launch for OLINVYK. I’m pleased by the early interest we’ve received from hospital physicians and institutions across the country,” said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc. “Additionally, we continue to make exciting progress across our pipeline, with several upcoming catalysts this year.”
OLINVYK Commercial Launch
- OLINVYK commercially available. The Company has contracted with the three major wholesalers covering the majority of the acute care business. All three vial presentations of OLINVYK (1 mg/1 mL and 2 mg/2 mL single-dose vials; 30 mg/30 mL single-patient-use vials for patient-controlled analgesia) are now available for ordering.
- Ramp-up of customer engagement activities underway. Since the approval of OLINVYK, the Company has received inbound interest from a diverse set of institutions and engaged with a number of key opinion leaders who participated in the Phase 3 OLINVYK “real-world” multi-site safety study. Physicians continue to reinforce the value proposition of OLINVYK as a compelling new analgesic option for acute pain patients in the hospital and other controlled clinical settings.The comprehensive product dossier and detailed health economic model for OLINVYK are now complete and accessible to healthcare decision makers to facilitate formulary inclusion. The health economic model, which highlights OLINVYK versus IV morphine cost information, is expected to be published in 1H 2021.
In addition, the “Now Available” marketing campaign for OLINVYK has launched, which includes early digital engagement, launch emails to targeted healthcare professionals, and an updated website which provides product ordering and reimbursement information.
- Build-out of customer-facing team on track for deployment this quarter. The Company has completed hiring of its medical science liaisons (MSLs) and sales manager team, and it remains on track to complete hiring, training and deployment of its field commercial team this quarter. The Company today announced that it will be targeting 100 formulary acceptances in 2021. In response to the ongoing COVID-19 pandemic, the Company is employing analytics on a local and regional basis to monitor the impact on hospitals and ambulatory surgical centers, and to inform the safe and effective deployment of its customer-facing teams.
- All required CMS reimbursement submissions and registrations complete. The Company today announced that all submissions for permanent J- and C-Codes have been submitted to the Centers for Medicare and Medicaid Services (CMS) for OLINVYK. In the interim, as is customary for all new products, customers will use the miscellaneous J- and C-codes for reimbursement. This ensures that OLINVYK can be reimbursed in both the inpatient and outpatient setting until permanent codes are established. Market access resources are now available to customers which support reimbursement of OLINVYK at 95% of Average Wholesale Price (AWP) in advance of pass-through status being decided.
- COVID-19 trial for TRV027 on track to report topline data this quarter. TRV027 is being evaluated in a 60-person trial as a potential treatment for acute lung damage / abnormal blood clotting associated with COVID-19. Imperial College London is sponsoring and funding the study, with additional support through the British Heart Foundation Centre for Research Excellence Award.
- IND filing for TRV045 on track for 1H 2021. In December 2020, the Company presented nonclinical data supporting the potential utility of TRV045 to treat a variety of CNS disorders, including epilepsy, chemotherapy-induced peripheral neuropathy, and diabetic peripheral neuropathy. The Company is currently collaborating with the National Institutes of Health (NIH) to evaluate TRV045 in their screening programs for epilepsy and non-addictive treatment of pain.
Trevena, Inc., headquartered in Chesterbrook, PA, is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders.
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