Posted by Mike Havrilla on Tue, Feb 23, 2010 @ 03:13 PM
On 8/24/09, SLXP announced the FDA accepted for filing and designated for Priority Review the Company's New Drug Application (NDA) for rifaximin tablets 550 mg, seeking approval for the use of "maintenance of remission of hepatic encephalopathy (HE)" -- a condition in which severe liver disease contributes to an accumulation of toxic substances that impair brain function.
On 2/23/10, SLXP reported that the Gastrointestinal Drugs Advisory Committee of the FDA recommended by a vote of 14 to 4 in favor of the approval of XIFAXAN (rifaximin) Tablets, 550 mg for the maintenance of remission of HE with a final FDA decision expected by a goal action date of 3/24/10.
HE occurs frequently in patients with cirrhosis as a result of their end-stage liver disease. Rifaximin has been granted Orphan Drug designation by the FDA for use in hepatic encephalopathy, and the Company believes this designation will provide seven years of marketing exclusivity in the U.S. upon FDA approval of rifaximin for HE.
Xifaxan (rifaximin) tablets 200 mg is a gut-selective antibiotic with negligible systemic absorption of less than 0.4% and broad-spectrum activity in vitro against both gram-positive and gram-negative pathogens that is currently approved for the treatment of patients age 12 or older with travelers ' diarrhea caused by non-invasive strains of E. coli.
Disclosure: No positions
Posted by Mike Havrilla on Mon, Feb 22, 2010 @ 03:55 PM
On 2/22/10, FDA notified healthcare professional and patients that it is reviewing the primary data from a large, long-term clinical study, RECORD, on possible cardiovascular risks with the diabetes drug, Avandia (rosiglitazone), which is marketed by GSK.
In addition to the clinical trial, a number of observational studies of the cardiovascular safety of Avandia have been published and FDA has been reviewing these on an ongoing basis. These reviews are ongoing and no new conclusions or recommendations about the use of Avandia in the treatment of type 2 diabetes have been made at this time.
Once FDA completes its review of the data from the RECORD study, the Agency will present the totality of new and existing cardiovascular safety data on Avandia at a public meeting in July 2010 and will provide an updated assessment of the risks and benefits of the drug.
Posted by Mike Havrilla on Mon, Feb 22, 2010 @ 03:34 PM
DALLAS - Feb. 22, 2010 - When head and neck tumors - from sinus tumors to acoustic neuromas attached to the hearing and balance nerve at the base of the skull - are located in close proximity to such sensitive areas such as the brain and eyes, they are particularly dangerous due to possible brain injury, visionary risk or hearing loss.
At UT Southwestern Medical Center, neurosurgeons, head and neck surgeons and radiologists routinely consult on unique and complex cases as part of the Comprehensive Skull Base Program. A multidisciplinary team of head and neck surgeons, neurosurgeons, and radiation oncology specialists collaborate to confirm and diagnose such tumors, explain clearly to the patient what is happening, and, most importantly, offer the best options for treating the conditions. Dr. Pete Batra, associate professor of otolaryngology, and Dr. Sam Barnett, assistant professor of neurosurgery, co-direct the program.
"Being able to assemble the level of expertise needed for a specific tumor can be difficult in itself. But we consider it just as crucial to carefully coordinate care and treatment in a major academic medical center environment," Dr. Barnett said. "Cases here are presented at a weekly conference, where we can discuss face-to-face the nuances of each person's needs - the best approach, the potential pitfalls, the latest research - as well as the practical, hands-on experience of some of the world's top experts, who aren't just looking at medical records, but there in the room. We're extremely fortunate to have them on site."
UT Southwestern's Comprehensive Skull Base Program covers more than two dozen types of skull-base related conditions, including cerebrospinal fluid leak, sinus tumors, glomus tumors, meningioma, neurofibromatosis, pituitary neoplasms, sarcoma, squamous cell carcinoma, and acoustic neuroma.
The assembled expertise includes a range of hard-to-find specialties: otorhinolaryngology (head and neck surgery), neurosurgery, neuro-ophthalmology, neurologic oncology, radiation oncology, interventional radiology and pathology. The medical center is home to one of the world's premier neurological surgery centers with a state-of-the-art intensive care unit. Care also is coordinated with the renowned Harold C. Simmons Comprehensive Cancer Center .
Physicians are able to make precise preoperative plans thanks to the latest technology in high-definition MRI and computerized tomography (CT) scanners. Surgical teams can then often offer innovative lateral skull base approaches using the latest in image guidance and microsurgical techniques.
"Minimally-invasive techniques have revolutionized the field of skull base surgery," Dr. Batra said. "Many formerly inoperable tumors can now be reached using a telescope through the person's nasal passages without the need for facial incisions. In addition, surgery can be performed with minimal brain movement, thus minimizing complications and preserving normal neurologic and facial function."
At UT Southwestern, a wide variety of state-of-the-art radiation technologies are available including Cyberknife (stereotactic body radiation therapy), Gamma Knife, Image-guided and intensity-modulated radiation therapy.
In addition, the medical center offers ancillary services such as audiology, balance testing and rehabilitation. Patients can receive facial nerve rehabilitation on an outpatient basis after surgery, along with access to pharmacists who are board certified in this area to ensure safe drug delivery, social workers, dieticians, and the full spectrum of physical, occupational and speech therapists, so the continuum of care is complete.
"Follow-up is equally important," said Dr. Peter Roland, chairman of otolaryngology - head and neck surgery, "so having the entire continuum of care on site is a real plus, with professionals who know one another, work regularly together, bump into each other in the hallways and cafeterias besides attending meetings together.
UT Southwestern also conducts numerous related clinical trials. Current studies are looking at laser treatments and using MRIs to predict treatment responses.
Visit www.utsouthwestern.edu/patientcare/medicalservices/skullbasesurgery.html to learn more about UT Southwestern's clinical services in skull base surgery.