RapidRx

September 25, 2015
The US Food and Drug Administration (FDA) today approved two long-lasting insulin drugs from Novo Nordisk to improve blood glucose control in adults with diabetes mellitus after having rejected them in 2013 for lack of cardiovascular outcomes data.

The drugs, Tresiba and Ryzodeg 70/30, contain insulin degludec, which possesses a half-life of 25 hours and acts for least 42 hours.

Insulin degludecis the only active ingredient in Tresiba. Patients inject it subcutaneously once a day. Because of the drug’s extended coverage, patients do not need to take it the same time each day as with other basal insulins, leading some to call it the “Sunday-sleeping-in insulin.”

Ryzodeg 70/30 contains insulin aspart, a rapid-acting agent, as well as insulin degludec. Also an injectable, Ryzodeg is taken once or twice a day with any main meal, according to a news release from Novo Nordisk.

After its initial regulatory setback 2 years ago, Novo Nordisk launched a cardiovascular trial for insulin degludec called DEVOTE and submitted interim results to the FDA earlier this year when it reapplied for approval. The manufacturer expects the trial to wrap up in the second half of 2016.

In a news release, the FDA cited clinical trials showing that both Tresiba and Ryzodeg 70/30 reduced hemoglobin A1c in patients with type 1 and type 2 diabetes who had inadequate glycemic control at the outset. The reductions resembled those achieved by previously approved long-lasting insulin drugs.

The most common adverse effects reported for the two new drugs were hypoglycemia, allergic reactions, injection-site reactions, pitting at the injection site, itching, rash, edema, and weight gain. Patients who have increased ketones in their blood or urine should not take either drug, according to the FDA.

23 September 2015
Food allergies are growing in prevalence in developed countries, and 3% of children globally are allergic to cow’s milk. New research carried out on children with cow’s milk allergy has shown that structural differences in gut bacteria may be the reason why some children do not acquire tolerance.

Teams from the University of Chicago, IL, Argonne National Laboratory in Lemont, IL, and the University of Naples Federico II in Italy found that some infants gained tolerance to cow’s milk after being treated with probiotic formula, while others did not.

The Centers for Disease Control and Prevention (CDC) name allergies as the sixth leading cause of chronic illness in the US, affecting more than 50 million Americans and costing more than $18 billion annually in health care. In a study released by the CDC in 2013, food allergies among children increased by 18% from 1997 to 2007 and by 50% between 1997 and 2011.

The National Institute of Allergy and Infectious Diseases note that allergy to cow’s milk is common in infants and young children and can develop within days to months after birth. Symptoms include abdominal pain, hives and eczema, or colic and sleeplessness, as well as blood in the stool and poor growth, depending on the type of immune response involved.

It seems increasingly likely that modern environmental influences, including widespread antibiotic use, high-fat and low-fiber diets, reduced exposure to infectious diseases, Cesarean birth and formula feeding are factors.

These are believed to have altered the mutually beneficial relationship between humans and the bacteria that live in the gastrointestinal tract. This dysbiosis, or distorting of the structure of the microbial community, can cause allergies in those who are genetically prone to developing them.

In previous research, Roberto Berni Canani and colleagues from the University of Naples studied the reaction of infants with cow’s milk allergy to probiotic and nonprobiotic formula. One group was given a formula containing a form of the milk protein casein, supplemented with the probiotic bacterial species Lactobacillus rhamnosus GG (LGG). The other group was treated with a nonprobiotic formula.
Those who took the probiotic formula developed a higher level of tolerance, suggesting that probiotic formula is more helpful in overcoming cow’s milk allergy.

Dr. Nagler and her team identified a common class of mucus-associated gut bacteria that are instrumental in regulating how dietary allergens reach the bloodstream. They now believe that the way commensal bacteria regulate allergic responses to food may be different than what was previously thought.

The findings suggest that certain bacteria make children more likely to develop tolerance, and that tolerance is linked to the acquisition of specific strains of bacteria, including Blautia and Coprococcus, which produce butyrate.

Jack Gilbert, PhD, associate professor in the Department of Ecology & Evolution at the University of Chicago, group leader for microbial ecology at Argonne National Laboratory and co-author of the study, says:

“The ability to identify bacterial strains that could be developed as a way to therapeutics for treating food allergies is a fundamental advance. Translating these findings into clinical treatments is our next goal.”

27 August 2015
A test that identifies genetic information in the blood picks up sensitive amounts of DNA that can be used to shape decisions about cancer treatment.

One of the challenges of modern medicine is to know if and when a cancer patient will relapse. A new study shows that months before tumors are visible on hospital scans, a “mutation-tracking” blood test can pick up valuable signs of a cancer’s return.

The study, undertaken by researchers at The Institute of Cancer Research (ICR) and The Royal Marsden NHS Foundation Trust – both in the UK – is an important step toward changing the way cancer is monitored in the clinic and informing treatment decisions.

The clue to identifying a return of cancer cells is to look at circulating tumor DNA present in the blood. These are cancer cells left behind that may seed new tumors even after treatment.

By monitoring patients with blood tests taken after surgery, the study says, and then every 6 months in follow-up, the researchers were able to predict very accurately who would experience a relapse.

The study involved 55 women who had been successfully treated for early-stage breast cancer.
It was found those who tested positive for circulating tumor DNA were at 12 times greater risk of relapse compared with those who tested negative. In addition, the blood test was able to detect cancer recurrence an average of 7.9 months before any visible signs appeared.

Explaining what the researchers are attempting to achieve with the blood test, Kat Arney, science information manager at Cancer Research UK, told BBC Radio:

“They are looking for ways to detect DNA that has been shed by tumor cells into the bloodstream and saying can we use this DNA as a way of monitoring if the cancer is coming back – how it is changing, how it is evolving in the body – and then could we use that to monitor cancer and pick up potentially when it has come back without having to give scans or biopsies.”

“There are still challenges in implementing this technology […] but the information that it provides could make a real difference to breast cancer patients, ” added Dr. Nicholas Turner, team leader in molecular oncology at ICR and consultant medical oncologist at The Royal Marsden.
Findings could be applied to all breast cancer subtypes

Because the researchers were searching for mutations common to various breast cancer types, they found the test could be applied to all subtypes of the disease.

“This test could help us stay a step ahead of cancer by monitoring the way it is changing and picking treatments that exploit the weakness of the particular tumor, ” says Prof. Paul Workman, chief executive at ICR.

The potential of this new test, Arney told BBC Radio, is to “separate those mutations that are driving the cancer from all the other genetic chaos that is going on in there, looking at how we can target these particular gene faults in this particular person, and those are the same faulty genes that are driving their relapse when the cancer comes back.”

September 21, 2015

Patients with diabetic peripheral neuropathy who used a capsaicin 8% patch (Qutenza, Astellas Pharma) had more relief from pain and better sleep quality than those who received a placebo patch, according to a phase 3 study reported at the European Association for the Study of Diabetes (EASD) 2015 Meeting.

The results were presented as the company announced the patch has just been approved in Europe for the additional indication of the treatment of adult diabetes patients with peripheral neuropathic pain, either alone or in combination with other medicinal products for pain.

The capsaicin patch is already approved for use in the European Union for neuropathic pain, but that license excluded patients with diabetes. Similarly, in the United States, the capsaicin patch is approved for the treatment of postherpetic neuralgia, but this label doesn’t include diabetes patients.

At the EASD meeting, Malcolm Stoker, PhD, global medical lead at Astellas Pharma Global Development, the Netherlands, presented the findings of the randomized, placebo-controlled, double-blind STEP trial assessed the efficacy and safety of the patch, a dermal delivery system containing 8% capsaicin, vs placebo, following patients for 12 weeks

“We found that capsaicin 8% patch provides a statistically significant improvement in pain relief and sleep quality compared with placebo in these patients,” said Dr Stoker. The capsaicin patch “was well-tolerated, and safety was consistent with previous studies in postherpetic neuralgia and HIV-associated neuropathy.”

“The most commonly reported treatment-emergent adverse events were burning sensation [14% capsaicin, 2.7% placebo]; unsurprisingly, pain in extremity [10.8% vs 5.5%]; and application-site pain. There were no serious adverse events or deaths in either group,” Dr Stoker reported.

In conclusion, he added that the study extends the range of peripheral neuropathic pain etiologies for which the capsaicin 8% patch shows efficacy and safety.

August 18, 2015

After a long and controversial process, the US Food and Drug Administration (FDA) has approved the first-ever drug aimed at boosting female libido.

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a statement.

Flibanserin (Addyi) — also known as “Female Viagra” or “Pink Viagra” — will be marketed by Sprout Pharmaceuticals. It is approved to treat premenopausal women. The nonhormonal therapy — a 5-hydroxytryptophan (HT)(1A) receptor agonist and 5-HT(2A) receptor antagonist — was approved for hypoactive sexual desire disorder (HSDD). The HSDD diagnosis appeared in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-4), but was subsumed into a larger category of Female Sexual Interest/Arousal Disorder in the latest edition, DSM-5.

The once-daily 100-milligram tablet is to be taken at bedtime, and alcohol use will be contraindicated due to common side effects including drowsiness and dizziness. The label will include a boxed warning about the potential for increased hypotension or syncope with alcohol. The FDA is requiring Sprout to conduct three postmarketing studies in patients to better understand the interaction between flibanserin and alcohol. Concomitant use with moderate-to-strong CYP3A4 inhibitors — such as antifungals — will also be contraindicated and included in the boxed warning.

“HSDD is a very real problem for women,” Leah Millheiser, MD, director of the female sexual medical program at Stanford University School of Medicine, told Medscape Medical News. Dr Millheiser said that the condition is caused by an imbalance in neurotransmitters, and that “there is absolutely a need for a drug that’s been shown to be safe and effective.”