Usona Institute Clinical Trial of Psilocybin for Major Depressive Disorder Launching This Fall
Usona Institute launches its Phase 2 study of psilocybin for major depressive disorder this fall. The study, PSIL201, will be conducted at seven U.S. sites and will investigate the safety and efficacy of psilocybin for major depressive disorder (MDD). The open dates for the trial will vary by site, with the first sites scheduled to begin enrolling participants within the next two months.
ROVI Announces Positive Topline Results from Phase 3 study of Doria® in Patients with Schizophrenia
Congratulations to Dr. Kakar and his team on their participation on the ROVI trial. The trial met both their primary and secondary endpoints! Great job to all who worked on this trial!
Collaboration and Outsourcing: Easing Clinical Trials
Segal’s own, Dr. Rishi Kakar, published an article on Pharmatech Outlook’s magazine where he highlights that the key to a CRO’s (Contract Research Organizations) success lies in its ability to understand the issues encountered by clinical research sites when conducting a study. Hence, CROs need to be responsive to sponsor timelines and costs. Dr. Kakar points out that collaboration between sites, CRO’s and sponsors is key to defining and implementing standard approaches that promotes efficiency in a trial. Additionally, CRO’s must have the ability to treat sites and patients as valued partners.
FDA Advisory Committee Votes in Favor of LUCEMYRA™ (lofexidine) for the Mitigation of Opioid Withdrawal Symptoms
Segal Trials is proud to have worked on the clinical trials of this investigational product which is currently under priority review by the FDA. LUCEMYRA suppresses theneurochemical surge that produces the acute and painful symptoms of opioid withdrawal. “Today’s favorable recommendation brings us one step closer to providing evidence-based medication, and hope for recovery, to people who want to discontinue opioid use and are struggling with the agonizing symptoms of opioid withdrawal, one of the most powerful factors driving opioid dependence and addictive behaviors.”
FDA Approves New HPV Test that Detects and Identifies HPV Genotypes that put Women at High Risk for Cervical Cancer
Segal’s own, Dr. Steven Chavoustie, is proud to have worked on the clinical trials that brought this medication to market. This test detects 14 types of high-risk human papillomavirus (HPV) from specimens collected during a cervical cancer screening. This is a major breakthrough in detecting major cervical cancers, and our volunteers helped make it happen. Thank you to all of our volunteers, and our investigator, Dr. Chavoustie, and his staff, for conducting these trials.
A Salute to the Unsung Medical Heroes of Clinical Trials by CISCRP
We are proud to be highlighted in the USA Today Clinical Research Supplement for December 2017, which is part of CISCRP’s National Clinical Trial Outreach and Awareness Initiative. This supplement acknowledges and thanks clinical research volunteers for being medical heroes to millions of people. We would also like to recognize and thank all of our staff for their dedication and hard work in advancing medicine.
FDA Approves Symbiomix Therapeutics’ Solosec™ (secnidazole) Oral Granules for the Treatment of Bacterial Vaginosis in Adult Women
Segal’s Dr. Chavoustie worked on phase 2 and 3 of the clinical trials for Solosec – the First and Only Single Dose Oral Therapy Approved for Most Common U.S. Gynecologic Infection That Can Have Serious Health Risks if Inadequately Treated.
Dr. Chavoustie completed his undergraduate studies at the University of Miami in Coral Gables, Florida. He graduated Magna Cum Laude with a Bachelor of Science in Chemistry and received his MD degree from the University of Miami School of Medicine. He participated in multiple externships before completing an internship and residency in obstetrics and gynecology at Jackson Memorial Hospital. He then served as the Administrative Chief Resident from 1984 to 1985. He is a fellow of the American College of Obstetrics and Gynecology and is a Certified Clinical Research Professional with SOCRA.
Dr. Chavoustie joined Segal Trials as an Investigator in 2007. He has conducted and continues to conduct clinical research trials in the area of most women’s health, general medicine and addiction medicine. His expertise with implantable drug delivery systems led him to be the Implant Medical Monitor for several Phase Ill clinical trials.
Dr. Chavoustie authors Expert Review of Clinical Pharmacology on Buprenorphine implants in medical treatment of opioid addiction
Segal’s very own, Dr. Steven Chavoustie, authors an article, “Buprenorphine implants in medical treatment of opioid addiction,” which was recently published in the Expert Review of Clinical Pharmacology.
Researchers find nutritional supplement could help children with autism
Segal Trials’, Dr. Scott Segal, was interviewed about his research on Curemark’s autism trial.
Segal Trials is proud to support CISCRP in the latest USA Today supplement on Clinical Trials, released to raise the visibility of clinical research among patients and the public.
In Segal Trials continued effort to support patient engagement and clinical research awareness programs, we are proud to support CISCRP’s newly launched National Clinical Trial Outreach and Awareness Initiative to raise the visibility of clinical research and elevate the level of public and patient preparedness to navigate the clinical research process. As part of this initiative, we have collaborated with CISCRP to sponsor the release of a Clinical Trials supplement in the latest edition of USA Today.
Braeburn Pharmaceuticals Achieves Primary Endpoint in Pivotal Phase 2/3 Study of BB0817, Risperidone 6-month Implant for Treatment of Schizophrenia
Segal Trials Associate Medical Director and Principal Investigator of the trial, Dr. Rishi Kakar, is mentioned in Braeburn’s press release. “Compliance with medication is a very important clinical issue, and without it, serious consequences including relapse and hospitalization are more likely. Preventing non-compliance is an important goal for any successful clinical treatment.”
FDA approves first drug to treat tardive dyskinesia
Segal Trials’ Dr. Rishi Kakar, Dr. Scott Segal, and Dr. Eduardo Cifuentes are proud have worked on the clinical trials that brought this medication to market.
A toxic combination of declining social status, poor health and failed relationships is being blamed
Segal’s very own, Dr. Rishi Kakar, was interviewed by the Washington Times discussing the link between poor socio-economic support and addiction. “A lot of these individuals do not have proper access to treatment for their opioid addiction,” Kakar says.
Dr. Chavoustie co-authors consensus statement titled “State of Bacterial Vaginosis: Experts Explore Unmet Needs Facing Women and Providers”
Segal’s Dr. Steven Chavoustie helped to author the research paper, “Experts explore the state of bacterial vaginosis and the unmet needs facing women and providers,” recently published in the International Journal of Gynecology & Obstetrics.
CISCRP recognizes Segal’s commitment at this year’s AWARE for All event with a USA Today supplement as a supporter of Medical Heroes
As part of Segal’s continued efforts to support patient engagement and patient-centric initiatives, we are proud to share an advertisement that is running in the latest issue of USA Today, recognizing Medical Heroes – study volunteers who participate in clinical research – for their contribution to the future of medicine. This is an advertisement that CISCRP runs on an annual basis and we are happy to be a sponsor of this year’s important message: Thank You to the men and women who take part in clinical research for not only advancing knowledge about disease, but also improving medical treatments for generations to come.
FDA approves Intrarosa for postmenopausal women experiencing pain during sex
Segal’s Dr. Chavoustie worked on phase 2 and 3 of the clinical trials for Intrarosa (prasterone). The U.S. Food and Drug Administration approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause….
Bonnie Segal was interviewed by ACRP on how sites often leave money for billable activities on the negotiating table. “When it comes to negotiating a contract on behalf of a site, there’s no room anymore for someone who is not on their game,” Segal says.
Effect of Buprenorphine Implants on Illicit Opioid Use Among Abstinent Adults With Opioid Dependence Treated With Sublingual Buprenorphine
The PRO-814 Study Group investigators include Segal Trials’ own Eduardo Cifuentes, MD, Scott Segal, MD, and Rishi Kakar, MD.
“The average patient has little knowledge about what it means to participate in a clinical trial, and that’s a problem.” At Segal Trials, we are working on these key ideas to help increase public awareness and education regarding clinical research trials.
Seventeen Days after Receiving FDA Approval, Braeburn Pharmaceuticals Announces First Patients Have Received Probuphine® (buprenorphine) Implant
Our own Dr. Chavoustie was the first in the country to implant a patient with Probuphine, since it’s recent FDA approval in May 2016. In Braeburn’s press release, Dr. Chavoustie, who collaborated with the FDA to finalize the training program on the procedures, said that “The large number of qualified healthcare providers signing up for the Probuphine trainings is proof that the medical community sees the potential this new option may offer their patients,” said Dr. Chavoustie who collaborated with the FDA to finalize the training program on the procedures.
Watch this informative interview with Dr. Segal and a study volunteer as they speak about their experience with the newly FDA approved opioid implant.
“Patients do very well on the implant,” Segal says. “It takes relapse off the table for six months, so it’s not a constant daily struggle anymore.”
Bonnie Segal, Vice President and Co-founder of Segal Trials for Clinical Trials, discusses our work in the area of community outreach. With our dedicated team surrounding her, she pursues her vision of research education, collaboration and advocacy. Listen in as she explains the challenges and triumphs in this important endeavor.
Braeburn Pharmaceuticals Announces Commercialization Plans for Probuphine® (buprenorphine) Implant, Six-Month Treatment for Opioid Dependence
The architect of the training program, Dr. Steven Chavoustie, gynecologist at the Segal Trials, Miami, and Braeburn Pharmaceuticals collaborated with the FDA to finalize the training program on the procedures.
Segal Trials is proud to have worked on the clinical trials that brought this implant to market, but more importantly we are thrilled that individuals will be helped by this extraordinary implant.
FDA Approves Implant to Battle Opioid Addiction: Experts say steady dosing eliminates need to take medication daily to combat heroin, powerful painkillers
“It really reduces or eliminates cravings, and they don’t start searching around for opiates,” said Dr. Scott Segal, president and chief medical officer of the Segal Trials in Miami, one of the centers that participated in the clinical trials.
This week, the FDA could approve Braeburn Pharmaceuticals’ buprenorphine implant, which provides up to six months continuous treatment for the withdrawal symptoms and cravings of opioid dependence. Courtesy of Braeburn Pharmaceuticals
Our own Dr. Segal was interviewed in this segment regarding the implant expected to receive FDA approval this month.
This is an unforgettable & eye-opening PSA on opioid dependence & addiction. Segal Trials Dr. Steven Chavoustie, participated in this powerful PSA. Thanks to all of our Principal Investigators: Dr. Scott Segal, Dr. Rishi Kakar, Dr. Steven E. Chavoustie, Dr. Olga Lapeyra and Dr. Eduardo Ciffuentes for participating in our numerous opioid dependence studies.
WSVN — For those battling an addiction to prescription painkillers, it can be difficult to see a light at the end of the tunnel. Now local researchers say a tiny implant could prove to be a big…
An advisory committee recommended Tuesday that the Food and Drug Administration (FDA) approve an implant designed to reduce addicts’ cravings for heroin or prescription…
Braeburn Pharmaceuticals and Camurus Enroll First Patient in a Phase 3 Efficacy Trial of Long-acting Treatment for Opioid Dependence
Pharmaceuticals and Camurus announce that the first patient has been randomized in the double blind Phase 3 efficacy trial of CAM2038 in opioid-dependent patients.CAM2038 medications are designed for…
Neurocrine Announces Positive Results from Phase III Kinect 3 Study of NBI-98854 in Tardive Dyskinesia
Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that NBI-98854, a highly selective small molecule VMAT2 inhibitor, showed a statistically significant reduction in tardive…
Objective: Metronidazole vaginal gel (MVG) 0.75% is a US Food and Drug Administration–approved, 5-day treatment for bacterial vaginosis (BV). This study tested the hypothesis that …
A Selective Nociceptin Receptor Antagonist to Treat Depression: Evidence from Preclinical and Clinical Studies
Nociceptin/Orphanin FQ (N/OFQ) is a 17 amino acid peptide that binds to the N/OFQ peptide (NOP) receptor (Reinscheid et al, 1995; Meunier et al, 1995). The NOP receptor is expressed in widespread areas of the…
Buprenorphine Implants for Treatment of Opioid Dependence: Randomized Comparison to Placebo and Sublingual Buprenorphine/Naloxone.
Based on substantial efficacy data, international guidelines specify sublingual buprenorphine and methadone as first-line treatments of opioid dependence . Buprenorphine can be prescribed in office-based physi…