Cholesterol Drug Cuts Heart, Stroke Risks In Diabetic Women

The cholesterol-lowering drug fenofibrate cuts cardiovascular disease risks by 30 percent in women with type-2 diabetes, a new University of Sydney study reveals.

Published in Diabetologia, the five-year study of nearly 10,000 people with type-2 diabetes also assessed fenofibrate's impact on a range of lipoproteins and triglycerides (circulating blood fats) that elevate the risk of cardiovascular events such as stroke and heart attack, and the need for medical procedures such as coronary artery bypass graft surgery.

Among type-2 diabetic patients with an elevated risk of cardiovascular disease—those with high levels of triglycerides and low levels of “good” cholesterol (high-density lipoprotein or HDL)—fenofibrate cut adverse cardiovascular outcomes by 30 percent in women and 24 percent in men.

A previous smaller US study had suggested that fenofibrate was not beneficial for women. This new study recommends that fenofibrate be considered as a useful way to reduce the risk of cardiovascular disease in both women and men with Type-2 diabetes.

Fenofibrate stimulates the action of an enzyme that breaks down triglycerides and low-density lipoproteins. Stimulating this enzyme increases the breakdown of triglycerides (another type of blood lipid) and low-density lipoproteins in the bloodstream and raises HDL cholesterol.


Wii Balance Board Induces Changes in MS Patients

A balance board accessory for a popular video game console can help people with multiple sclerosis (MS) reduce their risk of accidental falls, according to new research published online in the journal Radiology. Magnetic resonance imaging (MRI) scans showed that use of the Nintendo Wii Balance Board system appears to induce favorable changes in brain connections associated with balance and movement.

Physical rehabilitation is often used to preserve balance, and one of the more promising new tools is the Wii Balance Board System, a battery-powered device about the size and shape of a bathroom scale. Users stand on the board and shift their weight as they follow the action on the television screen during games like slalom skiing.

While Wii balance board rehabilitation has been reported as effective in patients with MS, little is known about the underlying physiological basis for any improvements in balance.

Researchers recently used an MRI technique called diffusion tensor imaging (DTI) to study changes in the brains of 27 MS patients who underwent a 12-week intervention using Wii balance board-based visual feedback training. DTI is a non-conventional MRI technique that allows detailed analysis of the white matter tracts that transmit nervous signals through the brain and body.

MRI scans of the MS patients showed significant effects in nerve tracts that are important in balance and movement. The changes seen on MRI correlated with improvements in balance as measured by an assessment technique called posturography.

“The most important finding in this study is that a taskoriented and repetitive training aimed at managing a specific symptom is highly effective and induces brain plasticity,” said lead author Luca Prosperini, MD, PhD, from Sapienza University in Rome. “More specifically, the improvements promoted by the Wii balance board can reduce the risk of accidental falls in patients with MS, thereby reducing the risk of fall-related comorbidities, such as trauma and fractures.”


Viscot Medical Launches White E•Z Removable Ink Skin Markers

Viscot Medical recently introduced White E•Z Removable Ink to complement their existing green and red E•Z Removable Ink markers. E•Z Removable Ink comes off easily with an alcohol swab or water. It also eliminates the problem of patients walking out of the aesthetic procedure with ink marks on their face. It provides a clear, visible landmark for procedures. White E•Z Removable Ink is available as an economical mini-marker in trial packs of six and containers of 30 markers. The white color ink complements their existing green and red E•Z Removable Ink markers.


FDA Warns Against TBI Supplements

When it's back-to-school time, it's also back to football, soccer and other sports that may cause a head injury. That makes it prime time to exploit the public's rising concern about concussions, and some companies are offering untested, unproven and possibly dangerous products that claim to prevent, treat or cure concussions and other traumatic brain injuries (TBIs). The FDA says it's monitoring the marketplace and taking enforcement actions where appropriate, issuing warning letters to firms—the usual first step for dealing with claims that products labeled as dietary supplements are intended for use in the cure, mitigation, treatment, or prevention of disease. The agency is also warning consumers to avoid purported dietary supplements marketed with claims to prevent, treat, or cure concussions and other TBIs because the claims are not backed with scientific evidence that the products are safe or effective for such purposes. These products are sold on the Internet and at various retail outlets, and marketed to consumers using social media, including Facebook and Twitter, the agency says.

One common but misleading claim: Using a particular dietary supplement promotes faster healing after a concussion or other TBI. Even if a particular supplement contains no harmful ingredients, that claim alone can be dangerous, says Gary Coody, FDA's National Health Fraud Coordinator. “We're very concerned that false assurances of faster recovery will convince athletes of all ages, coaches and even parents that someone suffering from a concussion is ready to resume activities before they are really ready,” says Coody.

One of the first alarms that dietary supplements are promoted to treat TBI was raised by the U.S. Department of Defense. “We first learned from the military about a product being marketed to treat TBI, obviously a concern with wounded veterans. We were taken aback that anyone would make a claim that a supplement could treat TBI, which is a hot-button issue,” says Jason Humbert, a senior regulatory manager with FDA's Office of Regulatory Affairs. “That triggered our surveillance

In its initial surveillance, FDA identified two companies selling multiple products claiming to prevent and treat concussions and other TBIs. FDA sent letters in 2012 warning both companies that their products were not generally recognized as safe and effective for treating TBIs, that the products were misbranded and that unless various violations cited in the letters were promptly corrected, they could result in legal action taken without further notice, such as seizure or injunction. Both companies changed their websites and labeling.


Therapeutic Update

NUPLAZID (PIMAVANSERIN) RECEIVES BREAKTHROUGH THERAPY DESIGNATION

The FDA granted Breakthrough Therapy designation to Acadia Pharmaceuticals' Nuplazid (pimavanserin) for the treatment of Parkinson's disease psychosis. Nuplazid is a selective serotonin inverse agonist and, if approved, will establish a new and different pharmacological approach to treating psychosis.

Nuplazid has successfully completed a pivotal Phase III trial in Parkinson's disease psychosis, which the FDA has agreed can serve as the basis, together with supportive data from other studies, for a New Drug Application (NDA), Acadia reports. The company plans to submit the NDA to the FDA near the end of this year.

The drug is a proprietary small molecule that is a selective serotonin inverse agonist preferentially targeting 5-HT2A receptors believed to play an important role in psychosis. The company has reported positive Phase III trial results with Nuplazid, which has the potential to be the first drug approved in the United States for psychosis associated with Parkinson's disease. Nuplazid is administered orally once-a-day.

The Breakthrough Therapy designation was created by the FDA to expedite the development and review of drugs that are intended to treat serious or life-threatening conditions, according to Acadia. For indications without an approved therapy, drugs qualifying for this designation must show a substantial and clinically meaningful effect on an important outcome when compared with placebo. The Breakthrough Therapy designation is distinct from priority review, which can also be granted to the same drug if the relevant criteria are met.

VIMPAT APPROVED AS MONOTHERAPY FOR PARTIAL-ONSET SEIZURES

FDA has approved a supplemental new drug application (sNDA) for Vimpat (lacosamide) C-V as monotherapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older. This is a new indication for Vimpat, which is already approved in the US as adjunctive treatment for partial-onset seizures in patients in this age group. This new indication means that adults with partial-onset seizures can be initiated on Vimpat monotherapy, and patients already on an anti-epileptic drug can be converted to Vimpat monotherapy.

UCB also announced that the FDA has approved a new single loading dose administration option for all formulations of Vimpat, when used as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older.

The new single loading dose administration option for Vimpat as monotherapy or adjunctive treatment of partial-onset seizures in adults with epilepsy allows the initiation of Vimpat as a single loading dose of 200mg (oral or injection), followed approximately 12 hours later by a 100mg twice daily dose (200mg/day). The most common loading dose adverse events (≥5%) were dizziness, headache, paraesthesia and gait disturbance. The loading dose should be administered with medical supervision considering the Vimpat pharmacokinetics and increased incidence of CNS adverse reactions.

FDA APPROVES BELSOMRA, FIRST IN NEW CLASS OF SLEEP DRUGS

FDA has approved Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep. Belsomra is an orexin receptor antagonist and is the first approved drug of this type. Orexins are chemicals that are involved in regulating the sleep-wake cycle and play a role in keeping people awake. Belsomra alters the signaling (action) of orexin in the brain.

“To assist health care professionals and patients in finding the best dose to treat each individual patient's sleeplessness, the FDA has approved Belsomra in four different strengths—5, 10, 15, and 20 milligrams,” said Ellis Unger, MD, director of the Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research. “Using the lowest effective dose can reduce the risk of side effects, such as next-morning drowsiness.”

Belsomra should be taken no more than once per night, within 30 minutes of going to bed, with at least seven hours remaining before the planned time of waking. The total dose should not exceed 20mg once daily.

The most commonly reported adverse reaction reported by clinical trial participants taking Belsomra was drowsiness. Medications that treat insomnia can cause next-day drowsiness and impair driving and other activities that require alertness. People can be impaired even when they feel fully awake.

The effectiveness of Belsomra was studied in three clinical trials involving more than 500 participants. In the studies, patients taking the drug fell asleep faster and spent less time awake during the remainder of the night compared to people taking an inactive pill (placebo). Belsomra was not compared to other drugs approved to treat insomnia, so it is not known if there are differences in safety or effectiveness between Belsomra and other insomnia medications.

The FDA asked the drug manufacturer, Merck, Sharpe & Dohme Corp., to study next-day driving performance in people who had taken Belsomra. The testing showed impaired driving performance in both male and female participants when the 20mg strength was taken.

DUCHENNE MUSCULAR DYSTROPHY DRUG RECEIVES EU CONDITIONAL APPROVAL, EYES US IN 2016

PTC Therapeutics has received approval from the European Commission for “conditional approval” for ataluren (Translarna) to treat a subset of patients with Duchenne muscular dystrophy (DMD).

DMD is a genetic muscle diseases caused by a complete lack of a muscle protein called dystrophin. Ataluren is designed to change the way cells read the genetic instructions for the dystrophin protein so that functional dystrophin protein can be produced. It's known as a “stop codon read-through” drug. Ataluren is the first medication developed specifically for DMD dystrophy to receive approval in any country. (Other drugs, such as corticosteroids and cardiac medications, are used to treat these disorders, but they were not specifically developed for them.)

Conditional approval is a mechanism that the European Union uses to allow patients with serious or life-threatening disorders to receive a drug before it has gone through the full approval process. Conditional approval must be renewed yearly and can be revoked if confirmatory studies do not show a drug is safe and effective.

Conditional approval in the EU has no direct bearing on approval of a drug in the United States, but PTC plans to submit an application for approval of ataluren for DMD in the US in 2016, after completion of an ongoing, large-scale trial of this drug.