The FDA has approved Nucynta (tapentadol) for management of neuropathic pain associated with diabetic peripheral neuropathy when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. According to preclinical studies, the drug is a centrally acting synthetic analgesic, though the exact mechanism of action is unknown. In two randomized-withdrawal, placebo-controlled phase III trials, researchers studied patients who had at least a one-point reduction in pain intensity during three weeks of treatment and then continued for an additional 12 weeks on the same dose, which was titrated to balance individual tolerability and efficacy. These patients had significantly better pain control than those who switched to placebo. The most common adverse events associated with the drug were nausea, constipation, vomiting, dizziness, headache, and somnolence, but tapentadol was generally well tolerated.
A mouse model of abnormal adult-generated granule cells (DGCs) has provided the first direct evidence that abnormal DGCs are linked to seizures, researchers reported in the September 20 Neuron. To isolate the effects of the abnormal cells, investigators used a transgenic mouse model to selectively delete PTEN from DGCs generated after birth. As a result of PTEN deletion, the mammalian target of rapamycin pathway was hyperactivated, which produced abnormal DGCs that resembled those in epilepsy. “Strikingly, animals in which PTEN was deleted from 9% or more of the DGC population developed spontaneous seizures in about four weeks, confirming that abnormal DGCs, which are present in both animals and humans with epilepsy, are capable of causing the disease,” the researchers stated.
Patients with multiple sclerosis (MS) who receive gingko biloba 120 mg twice a day do not show improved cognitive performance, researchers reported in the September 18 Neurology. The investigators compared the performance of two groups of patients with MS who scored 1 SD or more below the mean on one of four neuropsychologic tests. Sixty-one patients received 120 mg of ginkgo biloba twice a day for 12 weeks, and 59 patients received placebo. The researchers evaluated participants’ cognitive performance following treatment and found no statistically significant difference in scores between the two groups. Furthermore, no significant adverse events related to gingko biloba treatment occurred, according to the study authors. Overall, the investigators concluded that gingko biloba does not improve cognitive function in patients with MS.
The Solitaire Flow Restoration device performs substantially better than the Merci Retrieval System in treating acute ischemic stroke, according to a study published in the online August 24 Lancet. In a randomized, parallel-group, noninferiority trial, the efficacy and safety of the Solitaire device, a self-expanding stent retriever designed to quickly restore blood flow, was compared with the efficacy and safety of the standard Merci Retrieval system. The 58 patients in the Solitaire group achieved the primary efficacy outcome 61% of the time, compared with 24% of patients in the Merci group, investigators said. Furthermore, patients in the Solitaire group had lower 90-day mortality than patients in the Merci group (17 versus 38). “The Solitaire device might be a future treatment of choice for endovascular recanalization in acute ischemic stroke,” the researchers concluded.
—Lauren LeBano