Full Press Release Details
Approval of OLINVYK in China
partner, Jiangsu Nhwa, receives approval from Chinese National Medical Products Administration (NMPA)
$3 million milestone to Trevena from Jiangsu Nhwa
million to Trevena expected on first commercial sale in China, based on ex-US Royalty-Based Financing with R-Bridge Healthcare
Fund, an affiliate of CBC Group
CHESTERBROOK, Pa., May 8, 2023 (GLOBE NEWSWIRE)
- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines
for patients with central nervous system (CNS) disorders, today announced that its partner in China, Jiangsu Nhwa, received formal approval
from the National Medical Products Administration for OLINVYK. It has been approved for use in adults for the management of acute pain
severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.
"We are very pleased to see our partners,
Jiangsu Nhwa, achieve this important milestone which will allow Chinese patients to benefit from OLINVYK," said Carrie Bourdow,
President and CEO of Trevena. "We have worked closely with our partners during their submission process, and look to our continued
collaboration as they move forward with launch and full commercialization of OLINVYK in China."
The Chinese regulatory agency (NMPA) accepted
the NDA in January 2022. The approval is based on results of two bridging trials conducted in China and also leveraged US clinical data.
Results from the bridging studies demonstrated that the safety, tolerability and pharmacokinetic profile of OLINVYK in Chinese patients
is consistent with what has been seen in other OLINVYK clinical trials. Jiangsu Nhwa has an exclusive license agreement for the development
and commercialization of OLINVYK in China.
Trevena is due to receive a $3 million milestone
payment from Jiangsu Nhwa with the approval. The Company is also eligible to receive $15 million upon first commercial sale of OLINVYK
in China, in connection with its non-dilutive royalty-based financing with an affiliate of R-Bridge Healthcare Fund (the R-Bridge Financing).
As part of the R-Bridge Financing, Trevena previously received a $15 million upfront payment and may receive an additional $10 million
upon achievement of either a commercial or financing milestone.
(oliceridine) injection
OLINVYK is a new chemical entity approved by
the FDA in August 2020. OLINVYK contains oliceridine, an opioid, which is a Schedule II controlled substance with a high potential for
abuse similar to other opioids. It is indicated 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 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 and doses greater
than 3 mg should not be administered. The cumulative daily dose should not exceed 27 mg. Please see Important Safety Information, including
the BOXED WARNING, and full prescribing information at www.OLINVYK.com.
ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES
OR OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS
AND MISUSE - OLINVYK exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to
overdose and death. Assess each patient's risk before prescribing OLINVYK, and monitor all patients regularly for the development
of behaviors or conditions.
LIFE-THREATENING RESPIRATORY
DEPRESSION - Serious, life-threatening, or fatal respiratory depression may occur with use of OLINVYK. Monitor for respiratory
depression, especially during initiation of OLINVYK or following a dose increase.
NEONATAL OPIOID WITHDRAWAL
SYNDROME - Prolonged use of OLINVYK during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening
if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required
for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate
treatment will be available.
RISK FROM CONCOMITANT
USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS - Concomitant use of opioids with benzodiazepines or other CNS depressants,
including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in
patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients
for signs and symptoms of respiratory depression and sedation.
INDICATIONS AND USAGE
OLINVYK is an opioid agonist indicated in adults
for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.
Because of the risks of addiction, abuse, and
misuse with opioids, even at recommended doses, reserve OLINVYK for use in patients for whom alternative treatment options [e.g., non-opioid
analgesics or opioid combination products]:
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 is contraindicated in patients with:
WARNINGS AND PRECAUTIONS
Adverse reactions are described in greater detail
in the Prescribing Information.
The most common (incidence 10%) adverse reactions
in Phase 3 controlled clinical trials were nausea, vomiting, dizziness, headache, constipation, pruritus, and hypoxia.
For medical inquiries or to report an adverse
event, other safety-related information or product complaints for a company product, please contact the Trevena Medical Information Contact
Center at 1-844-465-4686 or email MedInfo@Trevena.com.
You are encouraged to report suspected adverse
events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information,
including Boxed Warning.
Forward-Looking Statements
Any statements in this press release about future
expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical
development and trials of its therapeutic candidates, plans for potential future product candidates and other statements containing the
words "anticipate," "believe," "estimate," "expect," "intend," "may,"
"plan," "predict," "project," "suggest," "target," "potential,"
"will," "would," "could," "should," "continue," and similar expressions, constitute
forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially
from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs,
results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug
candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals,
including the Company's assessment of discussions with FDA; available funding; uncertainties related to the Company's intellectual
property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential
of the Company's therapeutic candidates and approved product; and other factors discussed in the Risk Factors set forth in the Company's
Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings
the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent
the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's
views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically
disclaims any obligation to do so, except as may be required by law.
Trevena, Inc. is a biopharmaceutical company focused
on the development and commercialization of innovative medicines for patients with CNS disorders. The Company has one approved product
in the United States, OLINVYK (oliceridine) injection, indicated in adults for the management of acute pain severe
enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company's novel pipeline
is based on Nobel Prize winning research and includes three differentiated investigational drug candidates: TRV045 for diabetic neuropathic
pain and epilepsy, TRV250 for the acute treatment of migraine and TRV734 for maintenance treatment of opioid use disorder.
For more information, please visit www.Trevena.com
Nhwa Pharmaceutical Co., Ltd. (SZ002262), founded in 1978, is a leading CNS company in China. Over the past 40 years, Nhwa is exclusively
dedicated to developing innovative and differentiated pipeline in the areas of anesthesia, analgesia, psychiatry and neurology via in-house
R&D and global partnership.