Breaking News
February 20, 2018 - Booze Beats Pot at Being Unhealthy: Oregon Poll
February 20, 2018 - Morning Break: ’20 Years Late’; Drugs in the Dirt; Catching Flu in the Dorm
February 20, 2018 - Another piece to the puzzle in naked mole rats’ long, cancer-free life
February 20, 2018 - Scientists identify four viruses that can produce insulin-like hormones
February 20, 2018 - New e-Health solution developed to prevent cardiovascular disease, dementia in senior citizens
February 20, 2018 - New genetic risk score could help guide screening decisions for prostate cancer
February 20, 2018 - Study finds higher risk of stroke among blacks with atrial fibrillation than whites
February 20, 2018 - Physical activity could be used as strategy for diabetes prevention
February 20, 2018 - Researchers develop sensing method for early detection of cancer and diabetes
February 20, 2018 - New wearable electronics could be game-changer for stroke rehabilitation
February 20, 2018 - Immune history influences person’s response to flu vaccine
February 20, 2018 - Serenity Now! Learn to Have Patience with Patients
February 20, 2018 - Computer simulation addresses the problem of blood clotting
February 20, 2018 - Persistent bloating can be a sign of ovarian cancer, warns charity
February 20, 2018 - Key protein involved in epigenetic regulation of gene expression guides skin cell renewal
February 20, 2018 - Heart attack symptoms often missed in women
February 20, 2018 - Diagnosis of celiac disease takes 3.5 years for patients who do not report GI symptoms
February 20, 2018 - Study reveals functional dynamics of ion channels
February 20, 2018 - Study explores link between mortality risk and combustible tobacco use
February 20, 2018 - ‘She Trusted Me, and I’d Turned Her Away’
February 20, 2018 - AbbVie and Voyager Therapeutics collaborate to develop new treatments for tauopathies
February 20, 2018 - Fast food makes the immune system more aggressive in the long term
February 20, 2018 - Therapeutic target for glaucoma could have treatment ramifications for Alzheimer’s and Parkinson’s
February 20, 2018 - Overcoming Negative Reviews | Medpage Today
February 20, 2018 - MyD88—villain of allergies and asthma
February 20, 2018 - Food scientists develop rapid screening technique to detect pesticide residue in vegetables
February 20, 2018 - Lab-grown cerebellar cells may help explain how ASD develops at molecular level
February 20, 2018 - Scientists explore connection between bad sleep habits and stiff blood vessels
February 20, 2018 - New Treatment Apalutamide (Erleada) Approved for Prostate Cancer That Resists Hormone Therapy
February 20, 2018 - Do You Really Need My Signature on That?
February 20, 2018 - HIV-1 genetic diversity is higher in vaginal tract than in blood during early infection
February 20, 2018 - Diabetes does not increase work-loss years due to early retirement
February 20, 2018 - Researchers aim to find out how PTSD affects decisions of police
February 20, 2018 - UH Cleveland Medical Center explores novel treatments for uterine fibroids
February 20, 2018 - Flu Vax Efficacy 25% Against Predominant H3N2 Strain So Far
February 20, 2018 - HIV screening most optimal at 25 years of age if no risk factors
February 20, 2018 - Loyola Medicine primary care physician offers advice to minimize risk of flu
February 20, 2018 - Safe sleep recommendations for parents that may help reduce child’s risk of SUID
February 20, 2018 - Why Do So Few Docs Have Buprenorphine Waivers?
February 20, 2018 - Low levels of alcohol good for the brain
February 20, 2018 - Experimental treatment improves invisible symptoms of a man with spinal cord injury
February 20, 2018 - Myriad’s EndoPredict offers better prediction of breast cancer recurrence, analysis shows
February 20, 2018 - Researchers identify fifteen genes that determine our facial features
February 20, 2018 - Morning Break: New Health IT Player; Luxturna No Bargain; Nuclear Freakout
February 20, 2018 - How does it compare? Hospice care at home, at assisted living facility, at nursing home
February 19, 2018 - Scientists develop water-soluble warped nanographene for bioimaging
February 19, 2018 - It’s Not Your Imagination: You’re Hungrier After Losing Weight
February 19, 2018 - Antihypertensive Use At Delivery Rising in Preeclampsia
February 19, 2018 - A centuries-old math equation used to solve a modern-day genetics challenge
February 19, 2018 - Liquid biopsies could be used as new predictive marker for metastatic TNBC
February 19, 2018 - Russian researchers develop new multi-layered biodegradable scaffolds
February 19, 2018 - Are ‘Vaccine Skeptics’ Responsible for Flu Deaths?
February 19, 2018 - Hidden genetic effects behind immune diseases may be missed, study suggests
February 19, 2018 - Emergency nurses experience regular verbal and physical abuse
February 19, 2018 - Study sheds light on biology that guides behavior across different stages of life
February 19, 2018 - Morning Break: Transgender Breast Feeding; Brazilian ‘Pro-Vaxxers’; Post-Stroke Exercise
February 19, 2018 - Meningitis vaccination strategy in Africa found to be effective, economical
February 19, 2018 - Researchers uncover how excess calcium may influence development of Parkinson’s disease
February 19, 2018 - Psoriasis drug also effective at reducing aortic inflammation
February 19, 2018 - Excess emissions can make serious contributions to air pollution, study shows
February 19, 2018 - Researchers reveal potential biological roots behind individuality
February 19, 2018 - Diabetes Drugs Differ on HF; School-Based Obesity Program Flop; Plaque Type in ACS
February 19, 2018 - Surgical infections linked to drug-resistant bugs, study suggests
February 19, 2018 - Poor awareness may hinder a child’s early dental care
February 19, 2018 - Research finds rising trend in incidence of merkel cell carcinoma
February 19, 2018 - Researchers uncover Ras protein’s role in uncontrolled cancer growth
February 19, 2018 - FDA Approves Apalutamide (Erleada) to Help Curb a Tough-to-Treat Prostate Cancer
February 19, 2018 - Educational Tool Boosts Cervical Length Screening
February 19, 2018 - Spider’s web inspires removable implant that may control type 1 diabetes
February 19, 2018 - Scientists develop fluorescent probe to identify cancer stem cells
February 19, 2018 - University Hospital of Santiago de Compostela participates in large pancreatic cancer study
February 19, 2018 - New blood test shows promise to revolutionize diagnosis of tick-borne diseases
February 19, 2018 - Report: Use, Not Price, Drives State Health Costs
February 19, 2018 - Emergency services crews often unprepared for diabetic crises
February 19, 2018 - Scientists in Sweden create DNA nanowires that offer hope for treatment of diseases
February 19, 2018 - ID Break: Clean Hands, Fewer Abx; $11 Million HIV Cure?; MenB Vax for Kids
February 19, 2018 - Patient exposure to X-rays depends on how dentists are paid
February 19, 2018 - Study reveals parents’ views toward children’s tanning bed use
February 19, 2018 - Shot may help reduce risk of shingles
February 19, 2018 - FDA approves first treatment to reduce risk of NSCLC progression
Trevena Announces FDA Acceptance for Review of New Drug Application for Olinvo (oliceridine) Injection

Trevena Announces FDA Acceptance for Review of New Drug Application for Olinvo (oliceridine) Injection

image_pdfDownload PDFimage_print

Treatment for Pain

Trevena Announces FDA Acceptance for Review of New Drug Application for Olinvo (oliceridine) Injection

January 2, 2018 — Trevena, Inc. (NASDAQ:TRVN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for Olinvo (oliceridine) Injection. The Company expects that the PDUFA date for the NDA will be in the fourth quarter of 2018. Olinvo is an investigational product for the management of moderate to severe acute pain. It is the first G protein biased ligand of the mu receptor designed to provide IV opioid pain relief with fewer associated adverse effects.

“The NDA file acceptance represents another major step in our progress towards delivering Olinvo to patients and healthcare providers in need of new options for managing moderate to severe acute pain in the hospital setting,” said Maxine Gowen, Ph.D., chief executive officer. “We look forward to working with the FDA as they evaluate the Olinvo application.”

About Olinvo (oliceridine) Injection

Olinvo is a next generation IV analgesic for the management of moderate-to-severe acute pain in the hospital and similar settings and has been granted Breakthrough Therapy designation by the FDA. Olinvo was specifically designed to deliver the pain relief of a conventional IV opioid, with fewer associated adverse effects via its biased ligand mechanism of action. In Phase 2 and Phase 3 clinical trials, Olinvo provided rapid and powerful analgesic efficacy while demonstrating a wider therapeutic window compared to morphine, suggesting it may be highly effective and well-tolerated for patients in need of strong analgesia. OLINVO is an investigational product and has not been approved by the FDA or any other regulatory agency. The Company expects Olinvo to be a Schedule II controlled substance.

About Trevena

Trevena, Inc. is a biopharmaceutical company focused on providing better, safer therapies to patients in pain. The Company has leveraged breakthrough science to discover and develop its investigational product OLINVO for the management of moderate-to-severe acute pain. The Company has an early stage pipeline of new chemical entities targeting novel mechanisms of action, including for acute migraine, neuropathic pain, and other indications.

Cautionary note on 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 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; the uncertainties inherent in conducting clinical trials; expectations for regulatory approvals, including with respect to the OLINVO NDA and the timing of the PDUFA date; availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; uncertainties related to the Company’s intellectual property; other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates, including whether OLINVO will be a new option for managing moderate to severe acute pain in the hospital setting; 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.

Source: Trevena, Inc.

Posted: January 2018

Related Articles

Olinvo (oliceridine) FDA Approval History

Tagged with:

About author

Related Articles