Pain Management News: Adolor Corporation Completes Enrollment in Phase 2 OIC Program
Adolor Corporation Completes Enrollment in Phase 2 OIC Program
Adolor Corporation (NasdaqGM: ADLR) today announced that it has completed enrollment in its Phase 2 clinical evaluation of ADL5945 in chronic, non-cancer pain patients with opioid-induced constipation (OIC).
“Enrollment has progressed quite well in these studies”
Adolor is conducting two Phase 2 studies of ADL5945 in OIC patients in parallel. The first study is evaluating two doses of ADL5945 – 0.10 mg and 0.25 mg – given twice daily versus placebo over a 4-week, double-blind treatment period. The second study, of similar design, is evaluating 0.25 mg of ADL5945 given once daily versus placebo. The trials have enrolled 40 or more patients in each arm, for a combined total of over 200 patients.
“Enrollment has progressed quite well in these studies,” said Michael R. Dougherty, President and Chief Executive Officer. “We look forward to reporting results in the third quarter of this year, and to advancing ADL5945 into pivotal testing in the first quarter of 2012. OIC is a frequent and serious consequence of long-term opioid-based pain management and an effective treatment for this condition remains an unmet medical need.”
About ADL5945
ADL5945 is a potent, peripherally-acting mu opioid receptor antagonist intended to block the adverse effects of opioid analgesics on the GI tract without compromising centrally-mediated analgesia. Peripheral mu opioid receptors in the GI tract regulate functions such as motility, secretion and absorption. Stimulation of these GI mu opioid receptors by morphine, or other opioid analgesics, disrupts normal gut motility. Ultimately, this results in constipation, as well as other associated burdensome GI symptoms.
During 2010, Adolor completed single dose and multiple-ascending dose studies of ADL5945 that enrolled both healthy volunteers and chronic non-cancer pain patients on long-term opioid therapy with OIC. At target therapeutic doses, ADL5945 was well tolerated and, in patients with OIC, produced greater increases (over baseline) in weekly average number of spontaneous bowel movements as compared with placebo.
About OIC
According to IMS Health, over 250 million opioid prescriptions are written annually in the United States. For those patients treated with prescription opioids for long term pain management, it is estimated that approximately 50 percent will develop constipation. Currently, there are no FDA-approved therapies to treat opioid induced constipation in patients with chronic non-cancer pain.
About Adolor
Adolor Corporation is a biopharmaceutical company specializing in the discovery, development and commercialization of novel prescription pain and pain management products.
Adolor’s first approved product in the United States is ENTEREG® (alvimopan), which is indicated to accelerate the time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis. ENTEREG is available only for short-term (15 doses) use in hospitalized patients. Only hospitals that have registered in and met all of the requirements for the ENTEREG Access Support and Education (E.A.S.E.) program may use ENTEREG. For more information on ENTEREG, including its full prescribing information, the Boxed Warning regarding short-term hospital use and the E.A.S.E.® Program, visit www.ENTEREG.com. The Company co-promotes ENTEREG in collaboration with GSK.
The Company’s research and development pipeline includes: ADL5945 and ADL7445, novel mu opioid receptor antagonists undergoing clinical development for chronic OIC; and several earlier-stage compounds under development for the management of pain and CNS disorders.
Bethany Bodyworks Utilizes CranioSacral Therapy Advanced Pain Management Technique
CranioSacral Therapy, a relatively new holistic pain management system, designed to successfully treat headaches, neck and back pain, TMJ, chronic fatigue, motor coordination difficulties, eye problems and many other central nervous system disorders, is available at Bethany Bodyworks in New Haven, Connecticut.
Bethany, CT (PRWEB) June 03, 2011
The CranioSacral Therapy system, created by internationally renowned osteopathic physician John E. Upledger, has been hailed by one of his students, Bethany Bodyworks’ owner Jennifer Kriz, as a very effective method of holistic pain management that she has found to be highly beneficial to the pain management needs of many of her clients.
Ms. Kriz will be hosting an open house to explain and demonstrate CranioSacral Therapy at Bethany Bodyworks, 41 Village Lane, in Bethany, Connecticut on June 9th and again on July 14th, at 7:30 p.m. Bethany Bodyworks is conveniently located just off Route 63, just minutes north of the New Haven line.
Residents living and working in the greater New Haven, CT area, who suffer from debilitating conditions such as migraine headache, back and neck pain, chronic fatigue and many other nervous system disorders, will be happy to hear that Ms. Kriz effectively administers CranioSacral Therapy to her growing list of satisfied clients.
Jennifer Kriz is a member of the International Association of Healthcare Practitioners, an organization dedicated to advancing awareness and recognition of progressive approaches to wellness among the general public and healthcare providers.
Jennifer Kriz, who has been a trained CranioSacral Therapist for several years, is extremely confident in her ability to detect and correct a variety of imbalances often found in a client’s craniosacral system, which consists of the membranes and cerebrospinal fluid that surround and protect the brain and spinal cord. “CranioSacral Therapy (CST) is a gentle, hands-on technique that is used to detect and correct imbalances in the craniosacral system. Any imbalances found there may be the cause of many sensory, motor and neurological dysfunctions,” explains Ms. Kriz.
According to Kriz, CranioSacral Therapy has been successfully used to treat headaches, neck and back pain, TMJ, chronic fatigue, motor coordination difficulties, eye problems and many central nervous system disorders.
In addition to CranioSacral Therapy, Bethany Bodyworks also offers many other services, including Swedish Massage, Deep Tissue Massage, Sports Massage, Hot Stone Treatments, Reiki Energy Massage, and Foot Reflexology Massage.
VUMC Offers Women “Laughing Gas” as Pain Management Option During Childbirth
Vanderbilt University Medical Center is offering nitrous oxide as a pain management tool for women during childbirth – joining only two other hospitals in the country offering this option.
Vanderbilt University Medical Center is offering nitrous oxide as a pain management tool for women during childbirth – joining only two other hospitals in the country offering this option. Nitrous oxide, also called “laughing gas,” can be administered quickly, is widely known to rapidly ease pain, and has been proven safe for both mothers and their babies.
“Childbirth is not a one-size-fits-all process,” said Frank Boehm, M.D., professor of Obstetrics and Gynecology and vice-chair of the department. “Women deserve to have a wide variety of options available to them. Nitrous oxide is an option that takes the edge off of pain, and I think it may become a popular option for some women who give birth at Vanderbilt.”
The odorless, tasteless gas is inhaled through a mask. For labor, 50 percent nitrous oxide and 50 percent oxygen are blended together by a specialized device. The mixture is then self-administered by the mother through a mask or mouthpiece she controls. This mixture of nitrous oxide mixture is safe for both the mother and baby because it is eliminated from the body through the lungs, rather than through the liver. The 50-50 mix does not cause newborns to be groggy.
“Labor pain is subjective and highly individualized depending on the laboring woman,” said Michelle Collins, M.S.N., a certified nurse-midwife and assistant professor at Vanderbilt University School of Nursing. “So this is a wonderful way to provide a non-invasive option that provides pain relief for many women, particularly those who do not want an epidural or intravenous narcotics for pain.”
Nitrous oxide has many advantages including a quick response time. Most women experience its effects in less than one minute, and then it dissipates fully within five minutes after stopping use. It can be started and stopped at any point during labor, depending on the mother’s preference.
“A hallmark of using nitrous oxide in a labor environment is that the mother is able to self-administer via the mask,” said Sarah Starr, M.D., an assistant professor of Clinical Anesthesiology who works with Obstetrics patients. “This increases her sense of control over the dosage, over her pain and over herself during labor.”
“We want to offer women meaningful and different options. There is so much patient interest, we are happy to be able to provide this,” she added.
Nitrous oxide is commonly used for pain relief during childbirth in European countries. It was used in the United States in the 1950s, but was later replaced by other options including epidurals. At Vanderbilt, the provider and the patient will decide together if nitrous oxide is an appropriate option. If so, it will be initiated by an anesthesia provider who will teach the patient how to self-administer.
“Many women want to work through their labor and birth without medication or epidural anesthesia, but may find that they still need some sort of pain management to get them through the rough spots in their labor. Nitrous oxide is ideal in those situations,” Collins said.
Recently, VUMC has experienced a dramatic increase in the number of childbirths performed at Vanderbilt University Hospital, with an estimated 3,800 this year.
12 Great Physicians in Florida
Here are profiles of 12 great physicians in Florida. Physicians are listed in alphabetical order by last name. Note: Physicians do not pay and cannot pay to be on this list. This list is not an endorsement of any individual’s or organization’s clinical abilities.
Lora Brown, MD (Coastal Orthopedics & Pain Management, Bradenton, Fla.). Dr. Brown is a pain management physician at Coastal Orthopedics & Pain Management in Bradenton, Fla., where she has a professional interest in performing spinal injections, facet injections and implantable nerve stimulators. She has also served as the president of the Florida Chapter of the American Society for Interventional Pain Physicians as well as on the organization’s board of directors. During her career, Dr. Brown has also served on the Florida Governor’s Prescription Drug Monitoring Program, Implantation and Oversight Task Force. She is certified in both pain management and anesthesia. Dr. Brown earned her medical degree at the University of Texas in San Antonio and completed a fellowship in pain management at Cleveland Clinic.
Harold Cordner, MD (Florida Pain Management Associates, Sebastian). Dr. Cordner is the founder and sole physician at Florida Pain Management Associates. He treats a variety of conditions, including arthritic back pain, cancer pain, arthritis, failed back surgery and diabetic neuropathy. He is certified in both anesthesiology and pain management. In addition to his clinical practice, Dr. Cordner is a member of several professional organizations, including American Society of Interventional Pain Physicians, Society of Pain Practice Management, International Neuromodulation Society, and the International Spinal Injection Society. He also has experience lecturing nationally and internationally on pain management subjects. Dr. Cordner earned his medical degree at St. George’s University School of Medicine in the West Indies and completed his residency in anesthesiology at Monmouth Medical Center in Long Branch, N.J.
Jonathan Daitch, MD (Advanced Pain Management & Spine Specialists, Fort Myers, Fla.). Dr. Daitch founded Advanced Pain Management & Spine Specialists in Fort Myers, Fla., which is dedicated to treating patients with pain conditions. He is a fellow of the World Institute of Pain and an active member of the American Society of Interventional Pain Physicians. Prior to opening APMSS, Dr. Daitch served as a major in the U.S. Air Force Medical Corps at Wright Patterson Air Force Base. He earned his medical degree at Jefferson Medical College in Philadelphia and completed his residency in anesthesiology at Albert Einstein College of Medicine in Bronx, N.Y. His additional training includes interventional pain management experience at Wright Patterson AFB and board certification in pain management and pain medicine.
Richard A. Hynes, MD (Osler Medical, Melbourne, Fla.). Dr. Hynes is a spine surgeon at Osler Medical. He is a consultant for Medtronic and has participated in numerous FDA approved studies. Along with his clinical work, Dr. Hynes is also a director of TXEDAKA, a charity that helps low-income individuals gain access to the medical care they need. He is a fellow of the American College of Surgeons, the American College of Spine Surgeons and The American Academy of Orthopaedic Surgeons. Dr. Hynes earned his medical degree from Robert Wood Johnson Medical School (then Rutgers Medical School) in New Brunswick, N.J., completed his residency at Tripler Army Medical Center in Honolulu and received fellowship training in spine surgery at Harvard University in Boston.
Carlos J. Lavernia, MD (Orthopaedic Institute at Mercy Hospital, Miami, Fla.). Dr. Lavernia is the medical director of the Orthopaedic Institute and chief of orthopedics at Mercy Hospital in Miami. He also serves as the fist vice president of the American Association of Hip and Knee Surgeons and on the board of directors of the Florida Orthopaedic Society. Throughout his career, Dr. Lavernia has published several professional articles on topics such as the relationship of gender to primary hip arthroplasty outcomes, quality of life after total hip arthroplasty and imaging after hip and knee replacement surgery. He has also lectured across the world on knee and hip surgery and participated in Operation Walk, an organization that brings joint replacement surgery to underdeveloped countries, in places such as Peru, Guatemala and El Salvador. Dr. Lavernia earned his medical degree at the University of Puerto Rico and completed his residency at the University of California in Oakland. His additional training includes a fellowship in lower extremity reconstruction at the Johns Hopkins School of Medicine in Baltimore.
James S. Leavitt, MD (Miami Endoscopy Center, Miami). Dr. Leavitt is an assistant clinical professor at the University of Miami School of Medicine Department of Gastroenterology and a physician at the Miami Endoscopy Center and the Gastroenterology Care Center. He has served as a member of the American College of Gastroenterology’s practice management committee. Dr. Leavitt earned his MD from the State University of New York Downstate Medical School and completed his medical internship and residency and his gastroenterology fellowship at Jackson Memorial Hospital in Miami.
Mary I. O’Connor, MD (Mayo Clinic, Jacksonville, Fla.). Dr. O’Connor is a surgeon at the Mayo Clinic in Jacksonville, Fla., and the president of the American Association of Hip and Knee Surgeons. She also serves as a member of the Advisory Committee on Research on Women’s Health for the National Institute of Health. She has a professional interest in hip and knee replacement, computer-assisted surgery, limb-salvage surgery and pelvic tumors. During her career, Dr. O’Connor has published research on several topics, including osteoporosis screening for patients with hip fractures, hip resurfacing arthroplasty and stem fracture of conserve hemiarthroplasty. Dr. O’Connor earned her medical degree at Medical College of Pennsylvania and completed her residency and fellowship in orthopedics at Mayo.
Bharat Patel, MD (Deuk Spine Institute, Titusville, Fla.). Dr. Patel is the director of interventional pain management at Deuk Spine Institute in Titusville, Fla. He has a professional interest in interventional pain management, physiatry, electrodiagnostic medicine and musculoskeletal ultrasound diagnosis and injections. During his career, Dr. Patel has been chosen as an examiner for the national American Board of Interventional Pain Physicians examinations and served as the chair of the Congress RPC’s practice guideline committee. He is a member of the American Academy of Physical Medicine and Rehabilitation, International Spine Intervention Society and the American Academy of Pain Management. In addition to his clinical practice, Dr. Patel has conducted research on several topics, including ultrasound-guided trigger point injections into the cervicothoracic musculature. He earned his medical degree at Municipal Medical College in Ahmedabad, India, and completed his residency in physical medicine and rehabilitation at New York University School of Medicine in New York City. Dr. Patel’s additional training includes a fellowship in pain management and rehabilitation at The Florida Spine Institute in Clearwater.
Thomas F. Roush, MD (Roush Spine, Lake Worth, Fla.). Dr. Roush is spine surgeon with Roush Spine, which has four Florida offices. He is a member of several professional organizations, including North American Spine Society. Dr. Roush is a co-author of the 2009 book Motion Preservation Surgery of the Spine: Advanced Techniques and Controversies along with several other research publications. He has instructed courses on the anatomy of the spine at Duke University in Durham, N.C. Dr. Roush earned his medical degree from University of Cincinnati College of Medicine, completed his residency in orthopedic surgery at Duke University Medical Center in Durham, N.C., and received fellowship training in spine surgery and spinal arthroplasty at Texas Back Institute in Plano.
Alan Siegel, MD (Interventional Pain Physicians of South Florida, Plantation). Dr. Siegel is board certified in anesthesiology with a special certification in pain management through the American Board of Anesthesiology. He regularly treats chronic pain conditions and has a professional interest in diagnosis and treatment of spinal pain using minimally invasive techniques. He performs disc depression, discography, facet joint injections and epidural steroid injections. In addition to his clinical work, Dr. Siegel serves as a clinical assistant professor at Nova Southeastern College of Osteopathic Medicine in Ft. Lauderdale, Fla. Dr. Siegel is a member of the American Society of Anesthesiologists, International Spine Intervention Society and the American Society of Interventional Pain Physicians. Dr. Siegel earned his medical degree at the University of Florida College of Medicine in Gainesville and completed his residency in general surgery at New England Deaconess Hospital in Boston.
Sanford Silverman, MD (Comprehensive Pain Medicine, Pompano Beach, Fla.). Dr. Silverman is the director of Comprehensive Pain Medicine in Pompano Beach, Fla. He is a diplomate of the American Board of Anesthesiology and the American Board of Pain Medicine. He is also certified in addiction medicine by the American Society of Addiction Medicine. Dr. Silverman’s additional memberships include the International Spine Society and the American Academy of Pain Medicine. He has a professional interest in interventional and medical treatment for chronic pain, opioid adaptation and complex chronic pain with hyperalgesia. During his career, Dr. Silverman has served as the chief of anesthesia and operative service at William Beaumont Army Medical Center in El Paso, Texas, and the director of its pain clinic. He earned his medical degree from New York Medical College and completed his anesthesiology residency at Brooke Army Medical Center in San Antonio.
Andrea Trescot, MD (University of Florida, Gainesville, Fla.). Dr. Trescot is the director of the pain fellowship at the University of Florida in Gainesville and president-elect of the American Society for Interventional Pain Physicians. She is also a founding director and past president of the Florida Academy of Pain Medicine and a member of the World Institute of Pain. During her career, Dr. Trescot has authored textbook chapters and participated in the writing of four national pain guidelines. She has lectured nationally and internationally on topics such as cryoneuroablation, spinal endoscopy, opioids and peripheral nerve entrapments. Dr. Trescot earned her medical degree at the Medical University of South Carolina in Charleston and completed her residency at the National Naval Medical Center in Bethesda. Her additional training includes a pediatric anesthesia fellowship at National Children’s Hospital in Washington, D.C.