Breaking News
August 21, 2018 - New badge course explores research around skeletal muscle as an endocrine organ
August 21, 2018 - TG Therapeutics Announces Completion of Target Enrollment in the ULTIMATE Phase 3 Trials in Multiple Sclerosis
August 21, 2018 - Increased levels of human herpesvirus ID’d in Alzheimer’s
August 21, 2018 - To help patients quash pain, researcher develops practical guide for health care providers
August 20, 2018 - Medicine on the front line to be presented at Medical Innovation 2018
August 20, 2018 - Harbour Biomed and Kelun-Biotech collaborate to develop, commercialize anti-PD-L1 antibody
August 20, 2018 - The man who sold America on vitamin D — and profited in the process
August 20, 2018 - Finding the light in antimicrobials
August 20, 2018 - Unique pain program helps surgical patients wean off opioids safely and effectively
August 20, 2018 - Strawberries could mitigate colonic inflammation
August 20, 2018 - FDA Accepts New Drug Application (NDA) to Review Midazolam Nasal Spray, an Investigational Product for the Acute Treatment of Seizure Clusters
August 20, 2018 - Using Facebook to help young adults quit smoking
August 20, 2018 - ‘Liquid biopsy’ predicts lymphoma therapy success within days | News Center
August 20, 2018 - 5 Questions with Jordan Orange, Chair of Pediatrics
August 20, 2018 - New assay may help improve both sarcoma diagnosis and treatment
August 20, 2018 - New class of insect repellents to fight against mosquito-borne diseases
August 20, 2018 - ACA Coverage Gains Include Workers Without Insurance
August 20, 2018 - 3-D printed biomaterials for bone tissue engineering
August 20, 2018 - Current surveillance system does not quickly pick up most listeriosis cases in the EU, study reveals
August 20, 2018 - Prenatal exposure to acute stress can affect cognitive function in children of low-income households
August 20, 2018 - New study examines scope of state policies targeting drug use by pregnant women
August 20, 2018 - Researchers find long-term structural, functional brain abnormalities in individuals with AUDs
August 20, 2018 - Shortage of insurance fraud cops sparks campaign debate
August 20, 2018 - Researchers find STAT3 as therapeutic target for chronic active EBV infection
August 20, 2018 - Health Tip: Keep Diabetic Feet Healthier
August 20, 2018 - FDA approves brain stimulation device for OCD
August 20, 2018 - NYU Langone’s Perlmutter Cancer Center expands Blood and Marrow Transplant Program
August 20, 2018 - New drug shows potential to prevent painful side effect of therapy
August 20, 2018 - RDMD raises $3 million in seed funding to accelerate rare disease research, drug development
August 20, 2018 - Illicit drug use is higher during celebratory events, may be worse than previously thought
August 20, 2018 - Exploring the relationship between fever and cancer incidence
August 20, 2018 - Study reveals how socioeconomic status affects racial, ethnic disparities in childhood cancer survival
August 20, 2018 - Brain tumors trap immune cells needed to fight cancer in the bone marrow, finds research
August 20, 2018 - Three factors that contribute to physician burnout
August 20, 2018 - Babies dependent on opioids need touch, not tech
August 20, 2018 - Understanding How Antibodies Shape the Gut Microbiome
August 20, 2018 - Cara Therapeutics Doses First Patient in Second Pivotal Phase 3 Efficacy Trial of Korsuva (CR845/difelikefalin) Injection in Hemodialysis Patients with Chronic Kidney Disease-Associated Pruritus
August 20, 2018 - Kidney transplant chains more effective in saving lives
August 20, 2018 - Study unravels cellular and molecular mechanisms behind dermal condensate formation
August 20, 2018 - New integrated gene logic-chips could have great value in medical care
August 20, 2018 - FDA Advisory Committee Recommends Approval of Paratek’s Omadacycline
August 20, 2018 - Total, open repairs decline for abdominal aortic aneurysms
August 20, 2018 - Novel system can pinpoint ingestible implants inside the body using wireless signals
August 20, 2018 - Infection rates of high risk oral HPV in England found to be lower than expected
August 20, 2018 - Making robots as valuable and trustworthy assistants for medical therapies
August 20, 2018 - Patients with low-risk blood clots can be better treated at home than at hospital
August 20, 2018 - Passive smoking exposure among kids greatly increases COPD risk late in life
August 20, 2018 - Primary Care Provider Burnout Rate Low in Small Practices
August 20, 2018 - Discovery presents treatment hope for Alzheimer’s and other neurodegenerative diseases
August 20, 2018 - Stroke patients appear to receive better care at teaching hospitals with less chance of readmission
August 20, 2018 - Distinct origin of ADHD identified In children with history of traumatic brain injury
August 20, 2018 - AHA: Wildfire Smoke Threatens Health of Those Near and Far
August 20, 2018 - Here’s a mental health workout that’s as simple as ABC
August 20, 2018 - Newly discovered cytoskeleton utilized by cancer cells for survival
August 19, 2018 - Bifidobacteria supplement colonizes gut of breastfed infants
August 19, 2018 - Why patients with Alzheimer’s markers never develop the condition
August 19, 2018 - ACA’s Medicaid expansion associated with increase in prescriptions for opioid use disorder treatment
August 19, 2018 - Important factor may be missing in models used to predict spread of epidemics from climate change
August 19, 2018 - Indian-Americans have fewer sudden infant deaths, study finds
August 19, 2018 - Experts advise against universal genomic screening of newborns
August 19, 2018 - New trial to investigate whether weight loss before conception can make mom and baby healthier
August 19, 2018 - Sun Pharma Announces FDA Approval of Cequa (cyclosporine) Ophthalmic Solution to Treat Dry Eye Disease
August 19, 2018 - Researchers examining Parkinson’s resilience
August 19, 2018 - HPI, INTEGRIS and USPI enter into agreement to offer patients more choice, flexibility of care
August 19, 2018 - Researchers find mechanism that prepares brain to replicate repeated actions
August 19, 2018 - Those who are emotionally stable when young may remain the most stable as they age
August 19, 2018 - URI professor develops simpler and quicker method for detecting impurity in heparin
August 19, 2018 - Mayo Medical Laboratories and NDSC collaborate to develop new patient blood-management solution
August 19, 2018 - Insight into endocrine cancers and treatment options
August 19, 2018 - HPV Legislation Doesn’t Impact Teen Sexual Behaviors
August 19, 2018 - Exenatide treatment alleviated symptoms of depression in patients
August 19, 2018 - Tufts researchers win grant to study integration of genomic sequencing into neonatal care
August 19, 2018 - Novel finger-prick test can help prevent toxoplasmosis
August 19, 2018 - Cosmetic Procedures Boost Well-Being, Poll Shows
August 19, 2018 - Responsive parenting intervention results in lower BMIs through age three
August 19, 2018 - Anticancer drugs can help plants to battle infection
August 19, 2018 - Sunscreen from bathers releases significant quantities of polluting titanium dioxide into the sea
August 19, 2018 - Case Western Reserve gets three-year grant to enhance food systems in Cleveland neighborhoods
August 19, 2018 - Teenagers can thank their parents’ positive attitude for avoiding obesity
August 19, 2018 - Body mass index positively linked with blood pressure
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