Third Party Reexamination Of Javelin Pharmaceuticals' Phase III Trial Data For Ereska Yields Statistically Significant Primary Endpoint
Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV - News) announced that a reexamination conducted by a third party of pain score measurements from its Phase III study of Ereska™ (intranasal ketamine) showed that top line results for its primary endpoint were statistically significant. Previously, Javelin had reported that the top line results for its primary endpoint were not statistically significant. The previously disclosed top line results, based upon data captured by an external vendor, had inconsistencies whose presence was verified by a third party biostatistics company engaged by Javelin that thoroughly reexamined the trial's conduct and the initial primary analysis.
Research led by a scientist at Barrow Neurological Institute at St. Joseph's Hospital and Medical Center has opened the door for the advancement of a new category of painkillers, called TRPV1 antagonists. These drugs block the transient receptor potential vannilloid-1 (TRPV1) channel, which is the same receptor responsible for the sensation of hotness from hot peppers. However, clinical trials have revealed that TRPV1 antagonists cause hyperthermia - a dangerous, fever-like rise in body temperature. Research has shown that TRPV1 can be activated by several stimuli, including "pepper-like" chemicals, high temperatures and protons. The same channel is responsible for pain caused by these diverse stimuli.
Severe muscle injuries - such as crush injuries suffered in earthquakes, car accidents and explosions, and muscle damage from excessive exercise or statin drug interactions - can cause life-threatening kidney damage. Treatment has been limited to intravenous fluids and dialysis, but a new study suggests that the commonly used pain reliever acetaminophen may protect the kidneys from damage. An international research team led by investigators at Vanderbilt University Medical Center reports in the Proceedings of the National Academy of Sciences that acetaminophen prevented oxidative damage and kidney failure after muscle injury in a rat model.
Northwestern University researchers are the first to design a bioactive nanomaterial that promotes the growth of new cartilage in vivo and without the use of expensive growth factors. Minimally invasive, the therapy activates the bone marrow stem cells and produces natural cartilage. No conventional therapy can do this. The results will be published online the week of Feb. 1 by the Proceedings of the National Academy of Sciences (PNAS). "Unlike bone, cartilage does not grow back, and therefore clinical strategies to regenerate this tissue are of great interest, " said Samuel I. Stupp, senior author, Board of Trustees Professor of Chemistry, Materials Science and Engineering, and Medicine, and director of the Institute for BioNanotechnology in Medicine.
Decreased muscle strength is associated with difficulty in performing functional activities such as stooping, crouching, or kneeling (SCK) in older adults, according to an observational study published in the January issue of Physical Therapy, (PTJ) the scientific journal of the American Physical Therapy Association (APTA). These researchers found that adults with SCK difficulty had significant decreases in adjusted strength measurements of trunk extensor, knee extensor, and ankle flexion muscles. Concluding that measurements of strength predict SCK difficulty, their study sets the stage for research exploring whether rehabilitation programs that focus on training specific muscle groups are effective in improving functional performance and whether improvements in functional performance reduces falls in older adults.
QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced initiation of its second pivotal Phase 3 registration trial (Study 009) to evaluate analgesic efficacy and safety of MoxDuo™ IR, a patented 3:2 ratio fixed dose combination of morphine plus oxycodone. This two-arm study will compare the effectiveness and safety of a flexible MoxDuo™ IR dose regimen to a fixed low dose for managing moderate to severe pain in patients who have undergone total knee replacement surgery. The Company expects to complete dosing in Q3 2010 in preparation for filing a New Drug Application (NDA) with the US Food and Drug Administration in Q4 2010. MoxDuo™