November 28, 2016
Recro Pharma, Inc. (Nasdaq:REPH), a revenue generating specialty pharmaceutical company focused on products for hospital and ambulatory care settings, currently developing non-opioid products for the treatment of serious acute pain, today announced positive results from its second of two Phase III clinical trials evaluating intravenous (IV) meloxicam for the treatment of acute postoperative pain. In this trial, IV meloxicam achieved the primary endpoint of a statistically significant difference in Summed Pain Intensity Difference (SPID) over the first 24 hours (SPID24), compared to placebo, in patients following abdominoplasty surgery. With the positive data from this study, the Company believes this completes the efficacy program for the IV meloxicam New Drug Application (NDA)…
“The data from this trial demonstrated that IV meloxicam achieved a statistically significant difference in SPID24 pain relief following abdominoplasty surgery, a favorable safety and tolerability profile, and impressive impact on the number of times patients required rescue throughout the 0-24 and 24-48 hour periods, as well as the percent of subjects with ≥30% improvement at 24 hours,” said Neil Singla, M.D., Chief Scientific Officer of Lotus Clinical Research. “These data are important because they show that, if approved, IV meloxicam has the potential to be a new, non-opioid alternative for patients with moderate-to-severe pain following soft tissue surgery.”
July 26, 2016
Recro Pharma, Inc. (Nasdaq:REPH), a revenue generating specialty pharmaceutical company focused on products for hospital and ambulatory care settings that is currently developing non-opioid products for the treatment of serious acute pain, today announced positive results from its Phase III clinical trial evaluating intravenous (IV) meloxicam (N1539) for the treatment of acute postoperative pain in patients following bunionectomy surgery. In the trial, IV meloxicam achieved the primary endpoint of a statistically significant difference in Summed Pain Intensity Difference (SPID) over the first 48 hours (SPID48) compared to placebo…
"The data from this trial demonstrated that IV meloxicam provided rapid and sustained pain relief following bunionectomy surgery, a favorable safety and tolerability profile, and a statistically significant increase in time to opioid rescue medication,” said Neil Singla, M.D., Chief Scientific Officer of Lotus Clinical Research, and lead investigator of the study. “There are limited non-opioid pain relief options for postoperative patients suffering from moderate-to-severe pain, and these data support that, if approved, IV meloxicam has the potential to provide an important new non-opioid analgesic option for physicians and patients."
September 23, 2015
Neil Singla, MD, Chief Scientific Officer of Lotus Clinical Research, will chair the American Pain Society’s first Conference on Analgesic Trials
Neil Singla, MD, Chief Scientific Officer of Lotus Clinical Research, will chair the American Pain Society’s first Conference on Analgesic Trials (APS-CAT) on May 11, 2016 in Austin, Texas, as part of APS’ 35th Annual Scientific Meeting. The full-day session will discuss methods to optimize the complex process of analgesic drug development.
September 23, 2015
Dr. Neil Singla Presents at 9th Annual Pain & Migraine Therapeutics Summit in Washington DC
Neil Singla, MD, Founder & Chief Scientific Officer, Lotus Clinical Research, LLC presented "Soft Tissue Acute Pain Surgical Models: New Perspectives" at the 2016 Pain & Migraine Therapeutics Summit.
September 17, 2015
iX Biopharma Reports Success Of Single-Dose Wafermine™ Clinical Trials
Specialty pharmaceutical company iX Biopharma Ltd. (“iX Biopharma” or, together with its subsidiaries, “the Group”) is pleased to announce that its Phase 2a and 2b clinical trials for its lead product, Wafermine™, have proven successful. The results confirmed a rapid onset of pain relief, along with good tolerability. WafermineTM, is one of three iX Biopharma products currently under development and the world’s first oral- sublingual analgesic employing ketamine as its active compound.
September 9, 2015
AcelRx Pharmaceuticals' ARX-04 Meets all Endpoints in Pivotal Phase 3 Study for Moderate-to-Severe Acute Pain
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that ARX-04 (sufentanil sublingual tablet, 30 mcg) met primary and secondary endpoints in a multi-center, double-blind, placebo-controlled Phase 3 trial (SAP301) designed to study the short-term treatment of patients with moderate-to-severe acute pain following ambulatory abdominal surgery.
August 31, 2015
Trevena Announces Positive Results from Phase 2b Study of TRV130 in Acute Postoperative Pain
"The data from this trial showed that TRV130, when given on-demand, matched morphine efficacy for pain relief with a markedly improved safety and tolerability profile,” said Neil Singla, M.D., chief scientific officer of Lotus Clinical Research and lead investigator of the study. “The challenges of safely and adequately titrating morphine are well recognized, and these data suggest that, if approved, TRV130 may provide a better option than currently available opioid analgesics."
June 26, 2014
Dr. Neil Singla chairs a new special interest group at the IASP
Dr. Neil Singla chairs a new special interest group at the IASP titled: Clinical Trials. The purpose of the group is to explore methodological improvements in analgesic research.
Dr. Singla will also be speaking at the Acute Pain SIG. The talk is titled: “Decreasing placebo response and false negative outcomes in analgesic clinical trials.”
We will also have a booth #314. Please swing by our booth to learn more about our CRO and Site services and how we can help you with your clinical program.
May 5, 2014
WEBINAR: Expert Review of Recently Released FDA Analgesic Draft Guidance
In February of 2014 the FDA released a draft guidance document related to the development of drugs for analgesic indications. The importance of this document cannot be over emphasized in that it speaks to the current mindset of the FDA’s Division of Anesthesia, Analgesia, and Addiction Products (DAAAP). A multitude of topics are covered in it, including specific information regarding the following:
- The development of new molecular entities versus reformulations
- Requisite paths to specific analgesic indications
- Early phase requirements
- Appropriate endpoint selection
- Recommended strategies for administration of rescue medication
- Data imputation guidelines
- Acceptable patient reported outcomes etc.
April 1, 2013
Lotus to Present Scientific Poster at APS 2013
Lotus Clinical Research will be presenting a Scientific Poster at the American Pain Society’s 32nd Annual Scientific Meeting May 8-11 in New Orleans, LA entitled “A systematic review of the sensitivity of efficacy endpoints TOTPAR and SPID in acute pain”. Poster will be available on May 8th, 2013.
April 1, 2013
Dr. Neil Singla and Dr. Nathaniel Katz to chair the Clinical Trials SIG Session at APS 2013
The Clinical Trials SIG will discuss “Reducing the Risk of Failure in Analgesic Clinical Trials,” with presentations by Nathaniel Katz, MD MS, and Neil Singla, MD. Dr. Nathaniel Katz will discuss “An Evidence-Based Approach to Improving Assay Sensitivity in Clinical Trials” and Dr. Neil Singla will discuss
“Applying the Principles of Improved Assay Sensitivity in Analgesic Drug Development.”
Click here for more information on the upcoming APS Meeting
July 1, 2012
Dr. Neil Singla to present at the 6th Annual Pain Therapeutics Summit in San Jose, CA
Neil Singla, MD, Founder & Chief Scientific Officer, Lotus Clinical Research, LLC will be giving a presentation entitled “Minimizing experimental error in analgesic research by reducing placebo response and variability” at the 6th Annual Pain Therapeutics Summit. Read full story
April 6, 2012
Lotus to Present Scientific Poster at APS 2012
Lotus Clinical Research will be presenting a Scientific Poster at the American Pain Society’s 31st Annual Scientific Meeting May 16-19 in Honolulu, Hawaii entitled “Decreasing the number of clinical centers involved in an analgesic trial may increase the effect size and reduce the probability of a false negative” Click here to view poster presented at APS 2012
April 6, 2012
Dr. Neil Singla and Dr. Nathaniel Katz to chair the Clinical Trials SIG Session at APS 2012
The Clinical Trials SIG will discuss “Reducing the Risk of Failure in Analgesic Clinical Trials,” with presentations by Nathaniel Katz, MD MS, and Neil Singla, MD. Dr. Nathaniel Katz will discuss “An Evidence-Based Approach to Improving Assay Sensitivity in Clinical Trials” and Dr. Neil Singla will discuss “Applying the Principles of Improved Assay Sensitivity in Analgesic Drug Development.” Click here for more information on the upcoming APS Meeting:
January 4, 2012
ProFibrix US Phase II Study with FibrocapsTM Meets All Primary and Secondary Endpoints
Dr. Neil Singla, one of the Principal Investigators of the US Phase II study, said: “The combined ease of use and efficacy of Fibrocaps in spinal and vascular surgery constitute a great leap forward in hemostasis in these surgical settings…Read full story
August 25, 2011
Lotus Clinical Research, LLC
Lotus to Sponsor CHI’s Accelerating Proof-of-Concept Conference in Philadelphia, PA
Lotus Clinical Research, LLC is confirmed as a sponsor of CHI's third annual Accelerating-Proof-of-Concept: Clinical Success Driven by Science & Strategy conference. This conference will take place on October 3-5, 2011 at the Crowne Plaza Philadelphia Downtown, Philadelphia, PA... Read full story
August 10, 2011
Adolor Corporation Announces Positive Results from Phase 2 Program in OIC
“Opioid analgesics have become a cornerstone of multimodal therapy for the management of patients who suffer with chronic non-cancer pain,” said Neil Singla, M.D., lead investigator for the Phase 2 program… Read full story
September 10, 2010
Lotus Clinical Research, LLC
Lotus Clinical Research to present Assay Sensitivity Case Study at the upcoming ACCP Conference
Lotus Clinical Research will be presenting a poster entitled “Assay Sensitivity Can Be Higher in Single-Site than Multiple-Site Acute Pain Studies: A Case Study” at the upcoming American College of Clinical Pharmacology (ACCP) Conference … Read full story
September 8, 2010
IV Ibuprofen Lessens Morphine Use
“These findings are significant in that they not only confirm that Caldolor is effective in reducing both post-operative pain and morphine use, but also demonstrate that it can be safely administered prior to the induction of anesthesia,” said Neil Singla, M.D. … Read full story
August 30, 2010
Cumberland Pharmaceuticals, Inc.
Pre and Post-Operative Use of Caldolor® (Ibuprofen) Injection Significantly Reduces Pain and Opioid Use in Newly Published Study
“This gives physicians additional options for controlling the onset of post-operative pain, which can help improve patient comfort and thereby facilitate recovery” said Neil Singla, MD, Founder and Chief Scientific Officer of Lotus Clinical Research… Read full story
May 25, 2010
AcelRx Pharmaceuticals, Inc.
AcelRx Announces Positive Phase 2 Results
AcelRx Pharmaceuticals, Inc. today announced positive results from a Phase 2 clinical study evaluating the safety and efficacy of the ARX-02 Sufentanil NanoTab™ Breakthrough Pain Management System in the treatment of cancer breakthrough pain in opioid-tolerant patients. …Read full story
March 4, 2010
Cumberland Pharmaceuticals, Inc.
Key Caldolor(R) Orthopedic Data to Be Presented at American Academy of Orthopaedic Surgeons' Annual Meeting
Neil Singla, M.D., Chief Executive Officer of Lotus Clinical Research, Inc., is the principal investigator of the study and Byron Kaelin, BSHS, RN, Manager of Clinical Operations at Cumberland Pharmaceuticals Inc., is the presenting author…Read full story
November 15, 2009
The Medicines Company
Cleviprex Results Reported From Study In Patients With Intracerebral Hemorrhage
Cleviprex has proven to be safe and effective in this critical patient population requiring fast, precise blood pressure control within a target range. It is an important tool for physicians managing blood pressures in a variety of patients… Read full story
February 6, 2009
ROXRO Pharma, Inc.
Roxro Announces FDA Accepts for Review NDA for ROX-888 for the Management of Acute Moderate to Severe Pain
Dr. Neil Singla, Chief Executive Officer of Lotus Clinical Development, Inc. and lead investigator for ROXRO's second Phase 3 study said "ROX-888 could fulfill a compelling medical need for both clinicians and patients”… Read full story
December 1, 2008
The 2008 Pipeline Report – Breakthrough NSAIDS
"This is a drug that can be easily administered in a home environment," says Neil Singla, MD, of Lotus Clinical Research in Pasadena, CA. "That's a huge advantage."… Read full story
August 1, 2008
New Methods of reducing Pain Identified at Huntington
Surgery-related pain is being reduced at Huntington Hospital thanks to important research in pain management. Dr. Neil Singla heads an organization that is looking at the efficacy of medications targeting postsurgical pain… Read full story
May 5, 2008
Roxro Pharma Inc.
Roxro Pharma’s Phase 3 Intranasal Analgesic Data Receives Excellence Award
ROXRO PHARMA has received an Excellence and Innovation Award for the Phase 3 data of the company's novel intranasal pain reliever ROX-888, which is in development for the treatment of moderate-to-severe pain. Dr. Neil Singla was the lead author. ...Read full story
June 6, 2007
Roxro Pharma Inc.
Roxro Pharma’s Novel Intranasal Pain Reliever Effective, well tolerated in Phase 3 Study
“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… Read full story
September 1, 2007
Medical Staff Snapshot – Dr. Neil Singla
A specialist in post surgical pain and nausea management, Dr. Singla has published several articles in anesthesia journals and trade magazines. He is a compassionate patient advocate who works tirelessly towards the advancement… Read full story