Breaking News
May 20, 2018 - Why drug users prefer heroin at home, but cocaine while out
May 20, 2018 - Gene therapy that reverses blindness in dogs could also help treat humans
May 20, 2018 - Opioid-Related Payments Linked to Increase in Opioid Rx
May 20, 2018 - Phone apps push people to take their pills
May 20, 2018 - Backbreaking Work May Shorten Men’s Lives
May 20, 2018 - Harsher drug laws won’t stop violence, argues former police chief
May 20, 2018 - Cognitive decline in dementia is not reduced by exercise
May 20, 2018 - Detecting breast cancer with non-invasive ‘disease screening pill’
May 20, 2018 - Simple treatment may minimize hearing loss triggered by loud noises
May 20, 2018 - Alignment of mother and offspring body clock could prevent diseases such as heart disease and obesity
May 20, 2018 - New commercial data warehouse for life sciences
May 20, 2018 - Practice Intervention Targeting IV Opioids May Cut Exposure
May 20, 2018 - New study provides insight into blood signatures of inflammation
May 20, 2018 - Scientists make breakthrough discovery about vitamin B12
May 20, 2018 - What Causes Cancer? Misconceptions Abound
May 20, 2018 - Proper burial of dead cells limits inflammation
May 20, 2018 - Study offers novel solution to suppress metastatic spread of deadly breast cancer
May 20, 2018 - Perspectives of patients and caregivers on care transitions
May 20, 2018 - Guidelines for weight gain in pregnancy should be changed for underweight and very obese women
May 20, 2018 - Researchers transplant retinal sheets derived from human embryonic stem cells in retinal degeneration mouse models
May 20, 2018 - U.S. military personnel at greater risk for skin cancer than general population
May 20, 2018 - Your immune system holds the line against repeat invaders, thanks to this molecule
May 20, 2018 - Between death and deportation
May 20, 2018 - Developing a High Throughput Mass Spectrometry Platform for Drug Discovery
May 19, 2018 - New project aims to increase awareness among hospital clinicians of non-beneficial treatment at end-of-life
May 19, 2018 - Automated bone scan index offers accurate, speedy prognostic information about prostate cancer
May 19, 2018 - Rutgers Cancer Institute nurses research various topics to enhance patient experience
May 19, 2018 - Computer models provide valuable insight to structure and function of Ebola, Zika viruses
May 19, 2018 - Study exposes key tactic used by deadly fungus
May 19, 2018 - Bacterial signals are crucial to development of pre-leukemic myeloproliferation, study shows
May 19, 2018 - Global experts identify key issues in supporting children with brain injuries transition back to school
May 19, 2018 - Social connections may protect black men who have sex with men from acquiring HIV
May 19, 2018 - Study IDs Factors Linked to Quality of Life With Dementia
May 19, 2018 - Potassium — Consumer
May 19, 2018 - HIV-1 viruses transmitted at birth are resistant to antibodies in mother’s blood
May 19, 2018 - Some water pitchers are much better at removing toxins, shows research
May 19, 2018 - Scientists discover how unusually long strands of RNA help colon cancer cells avoid death
May 19, 2018 - International study finds viable treatment option for people with mild asthma
May 19, 2018 - Mayo discovery could enable development of personalized ovarian, brain cancer treatments
May 19, 2018 - ‘Superbug’ Surfaces at Poultry Farm in China
May 19, 2018 - UCLA-designed program helps former HIV-positive inmates maintain health after release from jail
May 19, 2018 - New blood test could help avoid more than 40% of prostate biopsies, study finds
May 19, 2018 - Macrophages play key role in maintaining stem cell niche of mammary gland
May 19, 2018 - Ferritin Blood Test: MedlinePlus Lab Test Information
May 19, 2018 - Prolonged exposure to air pollution leads to genetic changes in rat brains, study finds
May 19, 2018 - Scientists identify new potential target to combat acute myeloid leukemia
May 19, 2018 - Ovarian cancer therapy may help treat patients with aggressive pancreatic cancer
May 19, 2018 - MediciNova Announces Opening of Investigational New Drug Application for MN-166 (ibudilast) in Glioblastoma
May 19, 2018 - Research shows that sexual activity and emotional closeness are unrelated to the rate of cognitive decline
May 19, 2018 - Nuffield Council on Bioethics outlines ethical issues arising from use of AI in healthcare
May 19, 2018 - Pancreatic cancer patients with BRCA1 or BRCA2 mutations fare better on platinum-based chemotherapy
May 19, 2018 - Tradeshow Talks with nal von minden Ltd
May 19, 2018 - Chemist begins new project to develop carbohydrate mimics to assist cancer therapies
May 19, 2018 - Healthy Lifestyle for Healthy Older Adults
May 19, 2018 - Epstein-Barr virus linked to seven serious diseases
May 19, 2018 - Biochemists isolate protein supercomplex from bacteria that generates voltage
May 19, 2018 - Mindfulness-based Stress Management Course for cancer survivors
May 19, 2018 - Simple screening tool can help identify people at increased risk for dementia
May 19, 2018 - Many gay and bisexual teenage boys use adult hookup apps to connect with friends, partners
May 19, 2018 - Maternal Exposure to Polluted Air Tied to Elevated Child BP
May 19, 2018 - Experimental drug extends survival in progeria
May 19, 2018 - FutureNeuro and GreenLight Medicines team up to develop cannabis-based treatments for epilepsies
May 19, 2018 - Brazilians with less education more likely to perceive as being in poor health
May 19, 2018 - Experts available to discuss subjects related to Ebola virus
May 19, 2018 - Opioid Makers’ Perks to Docs Tied to More Prescriptions
May 19, 2018 - AI detects patterns of gut microbes for cholera risk
May 19, 2018 - Researcher develops small molecules that inhibit derailment of gene expression in cancer
May 19, 2018 - Study brings fresh insights into biology of malaria parasite
May 19, 2018 - Microglia may play key role in slowing progression of prion diseases, research suggests
May 19, 2018 - Safety program successfully reduces SSIs in patients undergoing colorectal operations
May 19, 2018 - Clinical study supports usual medical care plus chiropractic care for low back pain
May 19, 2018 - Vermont legislators pass a drug importation law. So what?
May 19, 2018 - Trump proposes cutting planned parenthood funds. What does that mean?
May 19, 2018 - Cognitive training intervention reduces gait freezing in Parkinson’s patients, study shows
May 19, 2018 - Clinical trial begins enrollment to test safety of experimental MERS treatments
May 19, 2018 - Scientists disrupt two enzymes to shrink cancer cells
May 19, 2018 - 3D simulation reveals beneficial impact of medically induced brain cooling
May 19, 2018 - Natural antioxidant bilirubin may provide cardiovascular benefits
May 19, 2018 - Lash Group introduces latest solution for electronic benefit verification
May 19, 2018 - New CRISPR/Cas9 system targets regulatory genes of AIDS virus
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