Archive for October, 2008

Novartis launches new doses of Stalevo

Novartis Pharmaceuticals Corporation has launched two new dosage strengths of its product Stalevo®, which is approved for use in treatment of Parkinson’s disease. With the approval of 75 and 125 tablets of Stalevo, physicians have another option to prescribe to patients who go through end-of-dose “wearing off”. The product simplifies treatment because it provides more sustained levodopa levels in the blood by combining it with the enzyme inhibitors carbidopa and entacapone.

FDA nod to UCB’s Vimpat as an add-on therapy for epilepsy

The U.S. Food and Drug Administration has given the approval to UCB’s Vimpat® (lacosamide) for use as an adjunct therapy in the treatment of partial-onset seizures in epilepsy patients older than 17 years of age. The novel anti-epileptic drug has an innovative mechanism of action which involves the modulation of activity of sodium channels in the nervous system. It prolongs the long-lasting resting condition of the channel, thereby controlling the hyperactive nerve cells.

Anti-inflammatory medications can treat schizophrenia: Study

Using positron emission tomography (PET) researchers associated with the journal ‘Biological Psychiatry’ have found out that a mechanism of brain inflammation is a major reason behind the development of schizophrenia. This has led them to suggest that anti-inflammatory agents hold a potential for use in the treatment of schizophrenia. They further maintain that medications under this category with powers to target, especially, the activation of microglia need to be studied.

Statins reduce AD risk: Study

A recent study has concluded that the use of statin drugs leads to reduction in the risk of Alzheimer’s disease (AD) by 67%. The multi-center trial assessed cognitive changes in the patients for four years. Widely used as drugs to lower cholesterol levels, statins are also safer drugs. Nymox Pharmaceutical Corporation holds global patent rights for the use of statins for the treatment of AD.

NICE recommends SCS for spine pain management

The National Institute for Health and Clinical Excellence has issued a guidance which recommends the availability of Spinal Cord Stimulation (SCS) to all patients suffering from chronic neurologic pain for a minimum of 6 months after note benefiting from conventional treatment for pain management. Before implantation, the patients would go through a trial of the treatment. The guidance is a ray of hope for patients with Failed Back Surgery Syndrome (FBSS). In this therapy, electric pulses are sent to electrodes attached to a fully implanted neurostimulator battery. They interrupt the pain messages sent to the brain.

FDA approves new administration option for RISPERDAL CONSTA

he U.S. Food and Drug Administration has provided the patients of schizophrenia with an administration option for RISPERDAL(R) CONSTA(R) ([risperidone] Long-Acting Injection) by approving a new injection site, the deltoid muscle in the arm. RISPERDAL CONSTA was previously approved as a gluteal injection only. The indication was given on the basis of a study which showed that the gluteal and deltoid injections of RISPERDAL CONSTA were bioequivalent routes of administration. The new site is also safe and tolerable. The new packs of RISPERDAL CONSTA will now have two separate with the needle for deltoid injection being smaller gauge and shorter than the gluteal needle in length. RISPERDAL CONSTA is marketed in the U.S. by Janssen(R).

FDA clearance to US Spine’s Preference 2 Complex Spine System™

The U.S. Food and Drug Administration has cleared US Spine’s Preference 2 Complex Spine System™ for use in the United States. With this approval, US Spine makes an entry into the deformity and trauma market. Designed by some of the leading spine surgeons for the treatment of complex spinal conditions, the system is featured by a number of new components that include hooks, screws and rods. The anchoring implants in the system are featured by Helical Flange® Closure mechanism that reduces cross threading drastically and eliminates head splay.

FDA approval to AstraZeneca’s once-daily treatment for bipolar disorder

The U.S. Food and Drug Administration has approved AstraZeneca’s once-daily Extended-Release Tablets, SEROQUEL XR (quetiapine fumarate) for the acute treatment of episodes of depression and mania related to bipolar disorder. In the long term, patients suffering from this disease may experience depressive symptoms as long as three times to that of manic symptoms. It must be noted that this is the first such medication approved buy the regulatory authority for treating the serious psychiatric illness.

FDA nod to Neuronetics’ Neurostar TMS system

The U.S. Food and Drug Administration has cleared Neuronetics, Inc.’s NeuroStar Transcranial Magnetic Stimulation (TMS) system for treating Major Depressive Disorder in adults whose condition did not improve by the intake of minimally effective dose of an antidepressant. A non-systemic and non-invasive solution for depression, the NeuroStar TMS device delivers magnetic pulses to stimulate nerve cells of that area of the brain which is associated with depression. Patients do not need to be anesthetized and the whole outpatient procedure is over in 40 minutes.

FDA clearance to NeuroMetrix, Inc.’s UNIVERSAL Electrodes

The U.S. Food and Drug Administration has granted 510(k) clearance to NeuroMetrix, Inc.’s UNIVERSAL Electrodes. NeuroMetrix can, now, launch the electrodes which are to be used in conjunction with the company’s ADVANCE(TM) NCS/EMG System to perform studies in nerve conduction. The UNIVERSAL Electrodes are for single patient use and are disposable. These electrodes will allow doctors to stimulate and record from any peripheral nerve at both proximal and distal sites.

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