By jeremyc | October 18, 2015
The US Food and Drug Administration (FDA) has approved olodaterol (brand name Striverdi Respimat) for treating chronic obstructive pulmonary disease (COPD).
Striverdi Respimat is an inhaled spray and comes under the class of drugs known as long-acting beta-adrenergic agonists (LABAs). According to the FDA, the medicine works by keeping the airway muscles relaxed. It is recommended to be taken once a day over a long period of treatment.
COPD is the third biggest cause of death in the US and is often linked to smoking. It involves multiple lung conditions such as emphysema and chronic bronchitis. Patients may experience symptoms such as chest tightness, coughing, wheezing and others.
Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said, “The availability of this new long-term maintenance medication provides an additional treatment options for the millions of Americans who suffer with COPD.”
The drug was approved after its safety and efficacy was evaluated with respect to a placebo in over 3,100 COPD patients. Those who used the medicine reported improved lung function.
The FDA noted that Striverdi Respimat is linked to certain side effects, common ones including runny nose, coughs, upper respiratory tract infections and dizziness. It has also not approved the medication for asthma and has warned that asthma patients must not use the drug, as it raising the risk of asthma-related death. In addition, Striverdi Respimat is not to be used for treating suddenly occurring breathing problems, and for treating rapidly-progressing COPD, as it may lead to heart problems and blockage or narrowing of the airways.
By jeremyc | October 17, 2015
According to two new studies, proton pump inhibitors (PPIs) may be linked to a greater risk of chronic kidney disease. PPIs are commonly indicated for heartburn.
PPIs include the drugs Prilosec, Nexium and Prevacid. Although the current studies did find a correlation between the drugs and chronic kidney disease, there was no causal relationship established. One of the studies was led by Pradeep Arora, a nephrologist and associate professor at the SUNY Buffalo School of Medicine and Biomedical Science. He said, “It is very reasonable to assume that PPIs themselves can cause chronic kidney disease.
“Patients should only use PPIs for [U.S. Food and Drug Administration]-approved indications, and not to treat simple heartburn or [indigestion].”
Previous research has tied PPIs to short-term kidney problems such as acute interstitial nephritis and acute kidney injuries. Arora’s study involved over 24,000 chronic kidney disease patients in 2001-2008. One of four kidney patients were previously treated with a PPI. The researchers also found that PPIs were linked to a nearly two times greater risk of dying prematurely.
The second study was led by Benjamin Lazarus from Royal Brisbane and Women’s Hospital in Australia, and Johns Hopkins University in Baltimore. It looked at over 10,000 adults with normal kidney function during 1996-2011. PPI users were found to be up to 50 percent more likely to have chronic kidney disease as compared to non-PPI users.
By jeremyc | October 15, 2015
The US Food and Drug Administration (FDA) has approved Inspirion Delivery Technologies’ MorphaBond (morphine sulfate) extended-release oral tablets featuring abuse-deterrent properties.
MorphaBond is an abuse-deterrent ER-morphine that uses chemical and physical barriers without opioid antagonists or aversive agents. It features inactive ingredients that make the drug more difficult to adulterate for abuse or misuse, all the while maintaining its extended-release properties despite chemical or physical manipulation.
The new drug has been tested in vitro with commonly used manipulation methods for making extended-release opioids. According to laboratory test data in comparison morphine sulfate ER tablets, MorphaBond showed increased resistance to cutting, breaking and cutting using various tools. It forms a viscous material that resists needle passage when subjected to a liquid environment.
Lynn R. Webster, Principal Investigator, PRA Health Sciences, Salt Lake City, said, “The data from the clinical abuse potential study indicate that MorphaBond has properties that are expected to reduce misuse and abuse via the intranasal route of administration as the extended-release characteristics were largely maintained even after extensive manipulation of the formulation.
“Overall, the results indicate that MorphaBond has properties that are expected to reduce abuse or misuse via injection or insufflation; however, abuse by these routes is still possible.”
By jeremyc | October 14, 2015
The US Food and Drug Administration (FDA) has approved a new drug called aripiprazole lauroxil (brand name Aristada) for the treatment of adults with schizophrenia. The drug is an extended-release injection recommended to be administered every four-six weeks.
Mitchell Mathis, director of the Division of Psychiatry Products in the Center for Drug Evaluation and Research, FDA, said: “Long-acting medications to treat schizophrenia can improve the lives of patients. Having a variety of treatment options and dosage forms available for patients with mental illness is important so that a treatment plan can be tailored to meet the patient’s needs.”
The efficacy and safety of the drug was shown in a 12-week clinical trial with 622 acute schizophrenia patients who were stabilized with oral aripiprazole. The drug was able to maintain the effective of the treatment as compared to a placebo.
The drug was associated to side effects during the trial, most common being an urge to move constantly. Pharmaceutical firm Alkermes manufactures the medication.
By jeremyc | October 13, 2015
The US Food and Drug Administration (FDA) has extended the approved use of nivolumab (brand name Opdivo) for the treatment of advanced metastatic non-small cell lung cancer (NSCLC) in patients whose disease progressed after or during platinum-based chemotherapy.
Nivolumab works by targeting the PD-1/PD-L1 cellular pathway, helping the immune system fight the cancer cells. It was approved earlier in the year to treat advanced squamous NSCLC, and this recent approval expands its use for non-squamous NSCLC as well.
Richard Pazdur, director of the Office of Hematology and Oncology Products at the Center for Drug Evaluation and Research, FDA, said: “There is still a lot to learn about the PD-1/PD-L1 pathway and its effects in lung cancer, as well as other tumor types. While Opdivo showed an overall survival benefit in certain non-small cell lung cancer patients, it appears that higher expression of PD-L1 in a patient’s tumor predicts those most likely to benefit.”
The safety and efficacy of the drug for metastatic NSCLC was demonstrated in an open-label, international, randomized study with 582 patients, who were treated with docetaxel or nivolumab. The average survival rate for nivolumab was 12.2 months, while it was 9.4 months for docetaxel. Also, 19 percent of the nivolumab group saw a complete or partial tumor shrinkage for an average of 17 months, while just 12 percent of the docetaxel group saw the same effect, and for a shorter average period of six months.
By jeremyc | October 12, 2015
According to new Canadian research, younger women are less likely than men to take the necessary heart medications a year after suffering from a heart attack.
The study underscores previous data that indicate that fewer women take the drugs. The study was co-authored by Karin Humphries, an associate professor of cardiology at the University of British Columbia, in Vancouver. She said, “The gender gap in treatment initiation among younger women is an important finding because younger women have much worse outcomes after suffering a heart attack than do men of the same age.”
“This finding suggests that younger women should be treated aggressively, especially when we have medications that work.”
Women and men are generally prescribed ACE inhibitors, statins and beta blockers after a heart attack. The researchers looked at data on over 12,000 heart attack patients in the year or more prior to the study period.
For a minimum of 80 percent of the post-heart attack year, just a third of the survivors filled all teir prescriptions. Among the women aged less than 55 years, just 65 percent started taking their medications as prescribed, as compared to 75 percent of the men.
“There are two possible reasons why women take fewer cardiovascular medications than men in an outpatient setting,” Humphries said. “It is either a consequence of physicians’ prescribing behavior, or patients not taking their prescribed medication, or both.”
By jeremyc | October 11, 2015
A new study by the US Substance Abuse and Mental Health Services Administration’s Center for Behavioral Health Statistics and Quality has found that prescription narcotic painkiller abuse rates have declined slightly in the last ten years.
Despite the decline, the continuing abusers are using the drugs more frequently and are more likely to get addicted. The study was led by researchers including Beth Han, a statistician, who said, “It is encouraging that the percentage of nonmedical use of opioids [narcotics] decreased.”
“Most adults with prescription opioid [narcotic] use disorders or other substance use disorders neither receive treatment nor perceive a need for treatment”
A second report backs up this study’s results, with 80 percent of narcotic abusers failing to get treated for their addictions. Treatment rates remain stagnant for the most part since 2004, according to Johns Hopkins School of Public Health researchers.
Han’s analysis looked at over 472,000 adults participating in annual surveys on drug use from 2003 to 2013. It found a small drop in narcotic painkiller abuse between the first and last survey, along with a small drop in the number of people who abused the drugs for the first time in the previous year, down from 1 percent to 0.6 percent in 2003-2013. However, the percentage of abusers who said that they abused the drugs more frequently rose from 0.6 percent to 0.9 percent.
By jeremyc | October 10, 2015
According to a study from the Yale School of Medicine, the smoking cessation medication varenicline (brand name Chantix) worked better for women than men in the first year of treatment. A year later, it worked equally well for both genders.
The study was led by Sherry McKee, professor of psychiatry, who said, “Studies show that women have a harder time quitting smoking than men, even as quitting has shown greater benefits to women’s cardiovascular and respiratory health.”
“With this first comprehensive analysis of sex differences in the effectiveness of this drug, now women and their health care providers can better decide how to successfully quit and live longer, healthier lives.”
The study looked at clinical trial data from over 6,700 people who used the medication for quitting the habit. Not adjusting for other factors, the drug was similarly effective for men and women with a 53 percent quit rate after three months.
However, after accounting for the weaker placebo effect in women, the adjusted data revealed that Chantix was 46 percent more effective in improving the chances of quitting smoking in women versus men after a three-month period. After six months, it was 31 percent more effective in women than men in maintaining complete abstinence.
McKee noted, “While it’s clear that sex differences in varenicline [Chantix] efficacy exist, we don’t yet know why varenicline is particularly effective for women.”
The researchers reasoned that differences in the nicotine receptor system of each gender’s brain could be a cause for the difference in effectiveness.
By jeremyc | October 9, 2015
According to experts, including US Centers for Disease Control and Prevention (CDC) officials, the flu vaccine for 2015 may be particularly well-suited to fight the disease this season.
Experts claimed that the 2015 vaccine is a ‘good match’ against major flu virus strains this season, and will be more successful in preventing the disease than the vaccine shot from 2014. However, they stressed the importance of getting vaccinated each year.
Jay Zimmermann, of Penn State Hershey Medical Group Elizabethtown, said: “Flu vaccination is just like eating healthy and exercising: a regular habit that you should be doing to help maintain a healthy state. Getting the flu shot not only protects you, but also protects people around you.”
The CDC recommends that everyone aged over six months be vaccinated, except those for whom vaccinations are deemed harmful. It said, “Vaccination can reduce flu illnesses, doctors’ visits, and missed work and school, as well as prevent hospitalizations.”
Zimmermann said that the vaccine for 2015 will most probably protect against several prevalent flu virus strains, and the vaccine may still offer some protection even if the patient is infected with the ‘wrong flu’.
Zimmermann said, “There is some similarity between the strains and your body responds to the different parts of the virus differently.”
By jeremyc | October 8, 2015
According to a new study, the drug clomiphene may have greater effectiveness than letrozole for treating unexplained infertility.
The study was led by Esther Eisenberg, of the National Institutes of Health (NIH), and it found that clomiphene, which is the standard treatment for unexplained infertility in women, may result in a larger number of live births than letrozole, a proposed alternative treatment.
Eisenberg said, “Letrozole treatment offered no advantages over clomiphene treatment. Women in the letrozole treatment group had fewer live births, but four times as many multiple pregnancies as women in the clomiphene group.”
Letrozole is generally used for treating ovarian and breast cancer in post-menopausal women. Previous research has found that it could help women conceive with a lower multiple-birth risk than other options, and to promote fertility more than clomiphene in women diagnosed with polycystic ovary syndrome.
For this study, the researchers assigned 900 women one of three treatment groups: letrozole, clomiphene or gonadotropin. The women were prescribed the medicines for four straight menstrual cycles or until they became pregnant.
Around 47 percent of gonadotropin, 36 percent of clomiphene and 29 percent of letrozole women became pregnant. Live births took place in around 33 percent of gonadotropic, 23 percent of clomiphene and 19 percent of letrozole women.
Also, the clomiphene group had 1.3 percent multiple pregnancies, the fewest among the three groups.