Trevena Announces FDA Approval of OLINVYK (oliceridine) injection -- OLINVYK is a new chemical entity approved in adults for the management of acute pain severe enough to require an IV opioid analgesic OLINVYK product av

Announces FDA Approval of OLINVYK (oliceridine) injection

is a new chemical entity approved in adults for the management of acute pain severe enough to require an IV opioid analgesic

product availability expected in fourth quarter of 2020

funded through year-end 2021, including OLINVYK commercialization

to host conference call at 8:30 a.m., today, August 10, 2020

CHESTERBROOK, Pa., August 10, 2020 (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 the U.S. Food and Drug Administration

(FDA) has 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 will be commercially available when the U.S. Drug Enforcement Administration

(DEA) issues its controlled substance schedule in approximately 90 days.

"The approval of OLINVYK marks an

exciting step forward in Trevena's mission of translating cutting-edge scientific discovery into therapeutic benefit for

patients in need. I would like to thank all of the patients, investigators, and our employees who helped us achieve this important

milestone," said Carrie L. Bourdow, President and Chief Executive Officer. "We will work quickly to bring this novel

IV analgesic to patients and healthcare providers in need of alternative treatment options."

Each year, approximately 45 million hospital

patients in the United States receive an IV opioid to treat their acute pain. Many of these patients are complex and difficult

to treat, such as the elderly, obese, or renally-impaired. Current hospital trends suggest that the number of these complex patients

is growing, representing an increasing burden on the healthcare system.

OLINVYK is an opioid agonist that is the

first new chemical entity in this IV drug class in decades 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 FDA approval of OLINVYK was based on

results from the Phase 3 development program, which evaluated OLINVYK in over 1,500 patients with moderate to severe acute pain.

In two pivotal efficacy studies in hard- and soft-tissue surgical models, OLINVYK demonstrated rapid analgesic efficacy statistically

significant vs. placebo. In a large, open-label, "real world" safety study, OLINVYK was safe and well-tolerated in

a medically complex patient population, including the elderly, obese, and patients with comorbid conditions such as diabetes and

"Complex patients present unique

challenges in the management of their postoperative acute pain, due to the presence of medical comorbidities that can complicate

dosing," said Gregory Hammer, M.D., Professor of Anesthesiology, Perioperative and Pain Medicine, and of Pediatrics at Stanford

University. "OLINVYK represents a new alternative for clinicians, due to its rapid onset of action, effective pain relief,

and unique profile."

The Company 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 is committed to an ethical

and responsible marketing campaign for OLINVYK and will have safeguards in place to monitor for and mitigate the risk of non-medical

The Company also today announced $54.8

million in cash and cash equivalents as of June 30, 2020, which the Company expects will be sufficient to fund operating expenses,

including the commercialization of OLINVYK, through year-end 2021.

Conference Call and Webcast Information

The Company will host a conference call

and webcast with the investment community on August 10, 2020, at 8:30 a.m. Eastern Time featuring remarks by Carrie Bourdow, President

and Chief Executive Officer, Mark Demitrack, M.D., Chief Medical Officer, Robert Yoder, Chief Business Officer, and Barry Shin,

Chief Financial Officer.

OLINVYK Efficacy and Safety Data

The efficacy of OLINVYK was established

in two randomized, double-blind, placebo- and morphine-controlled studies which enrolled 790 patients with moderate to severe acute

pain (pain intensity of 4 on a 0-10 numeric rating scale) after orthopedic surgery-bunionectomy or plastic surgery-abdominoplasty.

In each study, patients were randomized

to one of three OLINVYK treatment regimens, a placebo-control regimen, or a morphine-control regimen. The loading dose for all

OLINVYK treatment regimens was 1.5 mg; demand doses were 0.1, 0.35, or 0.5 mg, according to the assigned treatment group; supplemental

doses were 0.75 mg. A lockout interval of 6 minutes was used for all PCA regimens. Etodolac 200 mg was available as rescue medication.

Patients using the approved OLINVYK doses of 0.35 and 0.5 mg had a statistically significantly greater SPID-48/24 than patients

The most common adverse reactions ( 10%)

in these controlled trials were nausea, vomiting, dizziness, headache, constipation, pruritus, and hypoxia. When stratified by

the 27 mg daily dosing limit, discontinuation of OLINVYK due to adverse reactions occurred in 4% of patients who received a daily

dose 27 mg, and less than 1% of patients who received a daily dose >27 mg.

In an open-label safety study of patients

with moderate to severe acute pain following a surgical procedure or due to a medical condition, a total of 768 patients received

at least one dose of OLINVYK. OLINVYK was administered via clinician-administered bolus dosing, PCA, or a combination of the two.

Bolus dosing was initiated at 1 to 2 mg, with supplemental doses of 1 to 3 mg every 1 to 3 hours, as needed, based on individual

patient need and previous response to OLINVYK. If OLINVYK was administered via PCA, the loading dose was 1.5 mg, the demand dose

was 0.5 mg, and the lockout interval was 6 minutes. Supplemental doses of 1 mg were given as needed, taking into account the patient's

utilization of PCA demand doses, individual patient need, and previous response to OLINVYK.

The most frequent condition treated in

the open-label safety study was postsurgical acute pain, and included (in order of decreasing frequency): orthopedic, gynecologic,

colorectal, general, plastic, urologic, neurologic (including spinal), bariatric, and cardiothoracic surgical procedures. Of the

768 patients treated with OLINVYK, 32% were age 65 years or older and 78% had a Body Mass Index 25 kg/m2. OLINVYK

was administered as needed; 55% of patients received OLINVYK via clinician bolus administration only, and 45% of patients received

OLINVYK via PCA self-administration or a combination of clinician bolus- and PCA self-administration. Discontinuation of OLINVYK

in this study due to adverse drug reactions occurred in 3% of patients who received a daily dose 27 mg and 1% of patients

who received a daily dose >27 mg.

Full Prescribing Information, including

the Boxed Warning, is available at www.OLINVYK.com.

IMPORTANT SAFETY INFORMATION

WARNING: ADDICTION, 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

Addiction, Abuse, 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

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 a new chemical entity indicated