Navigation Links
Roxro Pharma’s Novel Intranasal Pain Reliever Effective, Well,Tolerated in Phase 3 Study

Patients Using ROX-888 Required Significantly Less Morphine After Major Abdominal Surgery Company On Track To File NDA In 2008

MENLO PARK, CA (June 6, 2007) – ROXRO PHARMA Inc. said today that ROX-888, its novel intranasal analgesic, rapidly and effectively eased pain and was well tolerated by patients who had undergone major abdominal surgery in a Phase 3 clinical study.

"This completes our second and final Phase 3 clinical study," said ROXRO PHARMA’s Chief Scientific Officer Roger Whiting. The company intends to include fully analyzed data in its New Drug Application for submission to the U.S. Food and Drug Administration. "We are very pleased with the solid results of this Phase 3 study and are on track to file our NDA in the first half of 2008," Whiting said.

In the Phase 3 study, patients who received ROX-888 reported greater improvement in pain relief and required 22 percent less morphine in the first 24 hours following surgery compared to patients who had access to morphine alone. ROX-888 is an intranasal formulation of ketorolac, a non-steroidal anti-inflammatory medicine most often administered as an intramuscular injection or intravenously for the short-term treatment of moderately severe pain. "ROX-888 is an important breakthrough in treating pain," said Dr. Neil Singla, Director of Clinical Research at Huntington Memorial Hospital in Los Angeles. "It is rapidly absorbed into the bloodstream, and relieves pain as fast as an intramuscular injection. There is a need for new analgesics like ROX-888 that do not have the troublesome side effects and abuse risks associated with narcotic pain relievers." The Phase 3 double-blind, placebo-controlled study included 321 patients who had undergone major abdominal surgery. Patients were randomized to receive either intranasal ketorolac (30 mg) or placebo. All study participants had access to patient-controlled morphine. "Pain is at its greatest intensity in the first 24 hours following surgery," Dr. Singla said. "With the continued increase in out-patient surgeries, there is a growing need for alternatives to injections and intravenous administration of pain killers." ROX-888 is contained in an easy-to-use nasal spray for self-administration by patients when they require pain relief. "This would be particularly convenient in the ambulatory setting," Dr. Singla said. If approved, ROX-888 would be the first non-opioid intranasal analgesic indicated for the treatment of acute pain. "We are eager to bring a novel pain treatment option to patients" ROXRO’s Whiting said. ABOUT ROXRO PHARMA ROXRO PHARMA, Inc., of Menlo Park, Calif., is a privately owned specialty pharmaceutical company focused on the treatment of pain. Founded in 1999, ROXRO in-licenses promising drug candidates for rapid development in acute pain conditions. The company’s highly experienced staff engages a global network of external experts to conduct pre-clinical and clinical studies and to manufacture drug products. ROXRO plans to file with the FDA for approval of its lead compound, ROX-888 in 2008. # # #

Related medicine technology :

1. Tranzyme Pharma Presents Initial Phase IIa Data for its Novel Ghrelin Agonist, TZP-101, in Patients with Diabetic Gastroparesis
2. Anacor Identifies a Novel Mechanism for Its Lead Anti-Fungal Drug, AN2690; Findings Published in Science
3. Novelos Therapeutics Announces Encouraging Results in Ongoing Phase 2 Ovarian Cancer Trial at Dana-Farber/Partners Cancer Care
4. Prolexys Pharmaceuticals and Columbia University Researchers Publish Study on Anti-Tumor Properties of a Selective Small Molecule Anti-Tumor Agent With Novel Mechanism of Action
5. Algeta Demonstrates Targeted Cancer-killing Potential of Novel Alpha Particle Linked Antibodies in Leading Medical Journal Blood
6. Novel Mechanism Insights and Additional Data on CombinatoRx Drug Candidates to Be Presented at Upcoming EULAR Meeting
7. Anacor Clinical Study of AN2728, a Novel Anti-Inflammatory Compound, Shows Efficacy in Psoriasis
8. Metabasis Therapeutics Presents Results of Preclinical Studies for MB07811, Its Novel Product Candidate for the Treatment of Hyperlipidemia, at the Endocrine Societys Annual Meeting
9. Encouraging Clinical Activity of GSKs Novel Cancer Immunotherapeutic Confirmed in Phase II Study in Patients with Most Common Form of Lung Cancer
10. Clinical Data on ARIADs Novel mTOR Inhibitor, AP23573, To Be Presented at the ASCO Annual Meeting
11. VGX Pharmaceuticals Novel HIV and Pandemic Influenza DNA Vaccine Candidates Trigger Robust Immune Responses and Protection in Pre-Clinical Models
Post Your Comments:
(Date:6/24/2016)... Calif. , June 24, 2016  American Respiratory Labs (ARL), ... is now able to perform sophisticated lung assessments in patients, homes, ... , Inc. Patients are no longer limited to ... EasyOne PRO ® , ARL patients like Jeanne R. of ... in the comfort of her own home. ...
(Date:6/24/2016)... 2016 According to a new ... Pen Needles, Safety Pen Needles), Needle Length (4mm, 5mm, ... Mode of Purchase (Retail, Non-Retail) - Trends & Global ... the market for the forecast period of 2016 to ... Billion by 2021 from USD 1.65 Billion in 2016, ...
(Date:6/24/2016)... NAMUR , Belgium , ...  (NYSE MKT: VNRX), today announced the appointment of ... Board of Directors as a Non-Executive Director, effective ... the Company,s Audit, Compensation and Nominations and Governance ... Board, Dr. Futcher will provide independent expertise and ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... ... Austin residents seeking Mohs surgery services, can now turn to Dr. Jessica Scruggs ... for medical and surgical dermatology. , Dr. Dorsey brings specialization to include Mohs surgery, ... Micrographic Surgery completed by Dr. Dorsey was under the direction of Glenn Goldstein, MD, ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern ... Laude and his M.D from the David Geffen School of Medicine at UCLA. He ... Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article ... people are unfamiliar with. The article goes on to state that individuals are now ... of these less common operations such as calf and cheek reduction. The Los Angeles ...
(Date:6/24/2016)... ... June 24, 2016 , ... The ... in Dallas that it will receive two significant new grants to support its ... PHA marked its 25th anniversary by recognizing patients, medical professionals and scientists for ...
(Date:6/24/2016)... Rhinebeck, NY (PRWEB) , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of ... of companies that call for a minimum wage raise to $12 an hour by 2020 ... wage. This will restore the lost value of the minimum wage, assure the wage floor ...
Breaking Medicine News(10 mins):