Fabior Foam: FDA Approval for Acne Treatment
May 30, 2012 § Leave a Comment
Fabior Foam: FDA Approval for Acne Treatment
GlaxoSmithKline (GSK) has received a FDA nod to market Fabior (tazarotene) in the United States to tackle blackheads and pimples in acne sufferers.
The new treatment will be in the form of a topical foam to treat acne, known in medical circles as acne vulgaris. Fabior Foam is indicated to treat acne patients 12 years and older who have moderate-to-severe acne. Prescribed in the 0.1 percent strength, Fabior Foam is touted as the only topical foam with FDA approval for treating acne in patients 12 years and older.
“Stiefel is dedicated to meeting the needs of patients and dermatologists, and we believe Fabior foam will be an important treatment option for people with moderate-to-severe acne,” Stiefel VP North America dermatology Jean-Christophe May said.
FDA approval of Fabior was based upon data from from two studies (phase III). Double-blind and randomized trials were conducted for 3 months (12 weeks) involving 1,485 patients who had moderate-to-severe acne. Among the participants, patients who received and applied Fabior Foam showed a significant reduction in their lesion numbers. Reactions to the foam were reported at the site where applied, which included redness, irritation, exfoliation, and dryness.
In the United States, while anyone can develop acne, it is seen primarily in young adults and adolescents, where hormonal changes are prevalent. However, certain cosmetics, some medications, and heredity/genetics can also play a role in developing acne. It’s estimated that up to 50 million people in the United States battle acne, reports the American Academy of Dermatology.
Stiefel Laboratoris, a subsidiary of GSK developed Fabior Foam.
Pharmacy Headquarters Blog (PharmacyHeadquarters.com) Editorial Staff Copyright 2012 – All rights reserved
Two Studies Suggest Lucentis and Avastin Equally Effective in Treating Wet Age-Related Macular Degeneration (AMD)
May 29, 2012 § Leave a Comment
IVAN (UK Study)
In what is considered the largest trial carried out in the UK on eye disease, when compared head-to-head, scientists found Avastin and Lucentis equally effective in treating wet Age-Related Macular Degeneration.
The most common cause of elderly vision loss is age-related macular degeneration, or AMD. There are two types of AMD, namely dry AMD and wet AMD. The latter is the more severe form of the eye disease. AMD can cause central vision loss, making the ability to read, drive, and recognize faces challenging. In the end, AMD can take away a person’s independence and mobility.
Lucentis, or ranbizumab, has been labeled as the gold standard for treating wet AMD. However, another medication — Avastin (bevacizumab) — indicated for the treatment of various cancers is also commonly used as a more cost effective means to treat wet AMD off-label.
The European study, named IVAN, included 610 people diagnosed with wet AMD in 23 hospitals. The participants were randomly assigned to receive one of the two aforementioned drugs: Avastin and Lucentis. Patients were injected three times per month with the drug in the wet AMD eye, and would receive subsequent injections as needed.
The study findings revealed that the effects on both drugs on preventing vision loss were similar. In addition, one year results indicated that there was no functional difference in vision when the drugs were given as needed versus regularly every month.
IVAN’s study trial is a period of two years. As such, researchers are continuing to follow study participants, and will be delivering a more detailed analysis of the results at the end of the two year study period.
In the UK study, there was a slighly higher rate of heart attacks, strokes in heart failure among the Lucentis users compared to the Avastin users. However, when data from the UK Ivan study was combind with a U.S. CATT (Comparison of AMD Treatments Trials) study (see below), there was no difference in heart attack or strokes between the two medications.
Comparison of AMD Treatments Trials (CATT) study (United States)
In a related study, the Comparison of AMD Treatments Trials (CATT) study, has attested that the cancer drug Avastin is a cost effective treatment for patients suffering from AMD. The latest findings were published in the Journal of Opthalmology based upon two-year study results.
The study concluded that Avastin (bevacizumab) was an equally as good treatment for wet age-related macular degeneration as the 40 times more expensive Lucentis (ranibizumab).
Both the findings of the CATT trial and IVAN study comparison of the two drugs were presented at a Fort Lauderdale, Florida meeting at the Association for Research in Vision and Ophthalmology (ARVO) in May.
Pharmacy Headquarters Blog (PharmacyHeadquarters.com) Editorial Staff Copyright 2012 – All rights reserved
Locaserin: Government Advisors Recommend FDA Approval of New Obesity Drug
May 24, 2012 § Leave a Comment
The Endocrinologic and Metabolic Drugs Advisory Committee arm of the U.S. Food and Drug Administration (FDA) voted to recommend the approval of lorcaserin, a new obesity drug from Arena Pharmaceuticals, Inc. and Eisai, Inc.
The recommended approval comes when the same panel had rejected its recommendation in September 2010 over health concerns. However, the current recommendation received a voting of four against, 18 in favor, and one who abstained that the benefits of locaserin outweigh the risks.
In people who are clinically obese or overweight, Locaserin is indicated for weight loss and weight maintenance. It works by acting as a selective serotonin 2C receptor, noted in the press release.
About one-third of American adults are battling obesity, which raises the risk of heart disease, diabetes, and other illnesses. “It is not really the answer to the obesity problem, but it may be a steppingstone to help us out,” said Dr. Eric I. Felner, a pediatric endocrinologist at Emory University who was on the 18 who voted in favor of approval.
Although the FDA’s advisory committees provide recommendations to the FDA, its the FDA that has the authority in making the final decision. The FDA has until June 27, 2012 to decide whether to give approval for sales of the drug. While the FDA is not bound to take its committee’s recommendation advice of its advisory panels, in many cases it does.
If the FDA approves the sale of locaserin, it will be the first new weight-loss prescription medication in the United States in over 10 years.’
Pharmacy Headquarters Blog (PharmacyHeadquarters.com) Editorial Staff Copyright 2012 – All rights reserved
Plavix Goes Generic
May 23, 2012 § Leave a Comment
Plavix Goes Generic
Seven companies have been given the green light by the Food and Drug Administration (FDA) to market the generic form of standard dosage Plavix, or clopidogrel bisulfate, to pharmacies, which will give millions of patients a lower cost option who need to take the blood thinner to reduce their risk of heart attack and stroke.
“For people who must manage chronic health conditions, having effective and affordable treatment options is important,” said Keith Webber, Ph.D., deputy director of the Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research. “The generic products approved today will expand those options for patients.”
Plavix, brand name for clopidogrel, helps to avert heart attacks and strokes by preventing blood platelets from clumping, or sticking, together; or in other words harmful blood clots.
Plavix is prescribed in patients who have had a stroke or heart atttack, have hardening or narrowing of arteries causing circulation problems, have total or partial blocked artery (i.e. peripheral artery disease), or have some other heart conditions, such as unstable angina. The medication comes in the form of a tablet, taken by mouth.
The generic approval came at the heels of the patent expiration of Plavix, the world’s second best selling medication.
The FDA gave clearance to Apotex Corp., Aurobindo Pharma, Mylan Pharmaceuticals, Roxanne Laboratories, Sun Pharma, Teva Pharmaceuticals and Torrent Pharmaceuticals to sell the standard 75-milligram generic Plavix dosage. The agency also gave approval for Dr. Reddy’s Laboratories, Gate Pharmaceuticals, Mylan and Teva to sell the larger (300-milligram) dose of generic Plavix.
FDA-approved generic drugs are of the same strength and quality as brand-name medications, and their packaging and manufacturing must pass the identical strict quality standards as their brand-name counterparts do.
Pharmacy Headquarters Blog (PharmacyHeadquarters.com) Editorial Staff Copyright 2012 – All rights reserved
Treating Eczema with TacrolimusTreating Eczema with Tacrolimus
May 21, 2012 § Leave a Comment
Treating Eczema with TacrolimusTreating Eczema with Tacrolimus
A small pilot study revealed that atopic dermatitis, better known as eczema, may be treated effectively with oral and topical tacrolimus. During a 14 week treatment period of topical and oral tacrolimus of 12 patients, atopic dermatis severity scores were reduced by up to 70 percent.
The researchers noted that 42 and 33 percent of the participants suffered nausea/vomiting and diarrhea, respectively. Additionally, one patient (out of 12) had to drop out of the study due to elevated levels of creatinine and uric acid. However, the researchers noted that generally both the oral and topical formulations of tacrolimus were well tolerated.
“This is the first study that has evaluated oral tacrolimus as a possible treatment for atopic dermatitis,” Terrence C. Keaney, MD, of the University of California San Francisco, and study colleagues concluded in a presentation. “The results suggest that oral tacrolimus can be effective as a short-term treatment option for severe generalized atopic dermatitis and can be transitioned to topical tacrolimus smoothly.”
Atopic dermatitis is a chronic skin condition that includes itchy rashes, scaly skin, blisters, and dry and thickened skin. Although the condition is most common in babies and children, adults can develop atopic dermatitis at any time.
While it’s difficult to clearly define how many people are affected by the condition, scientists believe that an estimated 10 to 20 percent of babies and young children experience symptoms of atopic dermatitis. Its prevalence in adults is thought to be approximately seven percent.
The research was reported at a Society for Investigative Dermatology meeting and the National Center of Biotechnological Information published an abstract of the research, but results should be considered preliminary until they are published in a medical peer-reviewed journal. Additionally, authors recommend that a larger, randomized control study is needed.
Pharmacy Headquarters Blog (PharmacyHeadquarters.com) Editorial Staff Copyright 2012 – All rights reserved
Cholesterol-Lowering Medications Seem to be Working
May 15, 2012 § Leave a Comment
Cholesterol-Lowering Medications Seem to be Working
There’s some good news in the fight against high cholesterol. According to a April 2012 Centers for Disease Control and Prevention (CDC) report, the percentage of adults in the U.S. with high cholesterol declined by 27 percent for the period 1999 to 2010 — approximately a decade.
Experts think the decline in largely due to cholesterol-lowering drugs like Zocor, Crestor, and Lipitor, but believe other factors, such as quitting smoking eating habits, and exercise also contribute to the drop.
As it stands currently, 13 percent of adults in the U.S. have high total cholesterol, reports the CDC.
To arrive at their findings, data — which included blood tests and interviews — from National Health and Nutrition Examination Surveys was collected on nearly 6,000 U.S. adults. The standard set for total high cholesterol was 240 milligrams of total cholesterol per one deciliter of blood.
The government has a goal that the percentage of U.S. adults with total high cholesterol be 17 percent and under. This goal was achieved five and ten years ago for women and men, respectively.
Too much total cholesterol and low levels of HDL (“good”) cholesterol ups the risk of heart disease. Speak with your physician about having regular cholesterol screening.
Pharmacy Headquarters Blog (PharmacyHeadquarters.com) Editorial Staff Copyright 2012 – All rights reserved
Smoking While Pregnant Linked to Worse Asthma in Kids
May 14, 2012 § Leave a Comment
Smoking While Pregnant Linked to Worse Asthma in Kids
While asthma can affect a person of any age, it typically begins during childhood. It’s estimated that 22 million people in the United States have asthma, and practically six million of these are children, according to the National Heart Lung and Blood Institute. In light of these numbers and May being National Asthma Awareness Month, there’s a new study that is particularly relevant. And if there wasn’t already enough reasons to quit smoking, this study adds another one.
Kids of mothers who smoked while pregnant may have a tougher time managing their asthma than other children do, according to researchers out of University of California San Francisco. While the study didn’t prove that prenatal smoking caused more serious later in life asthma symptoms, but it did show a correlation. Other associations from prenatal smoking pointed out in the study were secondary asthma symptoms, like early-onset asthma, limitations on asthma-related activities, and daytime asthma symptoms.
In addition to the asthma correlation, smoking during pregnancy has been tied to low birth weight, certain birth defects, increased risk of miscarriage, and other pregnancy-related complications.
This new study offers more evidence and — hopefully motivation — for women to quit smoking before becoming pregnant. It also offers more support for physicians to ask expectant moms about smoking. Today, prescription medications like Chantix and Nicotine patches can help.
“Pregnancy is a great opportunity for smoking cessation,” said lead researcher Sam Oh. “This study provides more impetus for healthcare providers to ask about smoking at each visit,” he further commented said.
The study was published online on April 30, 2012 in the Journal of Allergy and Clinical Immunology.
Pharmacy Headquarters Blog (PharmacyHeadquarters.com) Editorial Staff Copyright 2012 – All rights reserved
Chantix Anti-Smoking Drug May Not Increase Heart Attack Risk
May 10, 2012 § Leave a Comment
Chantix Anti-Smoking Drug May Not Increase Heart Attack Risk
Popular smoking cessation drug Chantix does not pose a higher risk of heart attack or other severe heart disease problems, according to a review conducted by Judith J. Prochaska, associate professor at Department of Psychiatry and Center for Tobacco Control Research and Education, UCSF and Joan F. Hilton, professor at Department of Epidemiology and Biostatistics, University of California.
As part of this new study, Prochaska and Hilton analyzed 22 randomized controlled trials and looked at data on over 9,232 people; out of this large group of people 3,801 took a placebo pill, while 5,431 took Chantix — both for a treatment period of around three months.
The results of the study revealed that 0.63 percent and 0.47 percent of the Chantix and placebo group had a serious heart problem. In other words, the authors concluded that the number showed that Chantix was “neither clinically nor statistically” linked to an increased risk of heart problems.
Chantix, or varenicline, is a prescription medication used to combat a smoking addiction. It works by not only reducing the cravings for cigarettes, but also reducing the pleasurable effects of tobacco products, like cigarettes. Both these mechanisms working together can help people quit smoking. Varenicline received FDA approval in 2006.
The authors researched is published online in the journal BMJ.
Pharmacy Headquarters Blog (PharmacyHeadquarters.com) Editorial Staff Copyright 2012 – All rights reserved
Is Your Bedroom Sleep-Friendly?
May 10, 2012 § Leave a Comment
Is Your Bedroom Sleep-Friendly?
Want to get a better night’s sleep? Who doesn’t right? According to the first ever “Bedroom Poll” from the National Sleep Foundation, most people polled felt that the most important component to a sleep-friendly bedroom was a cool temperature.
What were some other important factors after a cool bedroom temperature participants cited?
- Fresh air (free of allergens)
- A bedroom that is dark
- A bed room that is quiet
- A bedroom that is clean
Additionally, 71 percent of the respondents indicated sleeping better on clean sheets, while nearly 80 percent said they were more excited about going to bed when they knew there were clean sheets on the bed.
Dr. Michael J. Breus, PhD, otherwise known as “The Sleep Doctor™”, offer a few helpful tips for keeping your bedroom in tip-top sleeping shape:
- Invest in a good mattress and pillow. Replace your mattress every 7 years — unless your body tells you otherwise — and your pillows every year.
- Keep your bedroom cool and dark when sleeping.
- Disengage from electronics one hour before bedtime.
- Change sheets frequently.
What’s the takeaway? The condition of your bedroom matters as far as sleep quality and quantity does. With that in mind, do what you can to make your bedroom your sleep sanctuary. Of course, if you’re still having difficulty sleeping even with a bedroom sleep haven, today there are a variety of non-habit forming prescription sleep aids that may be helpful on a temporary basis.
Pharmacy Headquarters Blog (PharmacyHeadquarters.com) Editorial Staff Copyright 2012 – All rights reserved
FDA Supports Truveda for HIV Prevention
May 9, 2012 § Leave a Comment
FDA Supports Truveda for HIV Prevention
The prescription drug Truvada, which has a long history of use for treating HIV, gains forward progress in becoming the first medication approved to help “prevent” people from becoming infected with the HIV virus that causes AIDS.
The FDA indicates that Truvada appears to be effective and safe for HIV prevention. The agency concludes that taking Truvada daily could help patients from contracting the virus that can preclude “a serious and life-threatening illness that requires lifelong treatment.”
When combined with counseling and condoms, a three year study revealed that a daily dose of Truvada cut the risk of infection in bisexual and healthy gay men by 44 percent. Another study found that the medication cut the risk of infection in heterosexual couples where one partner was infected with HIV and the other was not by 75 percent.
Because Truvada is currently marketed to treat HIV, some physicians already prescribe its use as a preventative measure. Should the FDA approve the drug for preventative use, Truvada’s manufacturer, Gilead Sciences, could formally market the medication for its HIV preventative use.
The HIV virus attacks the body’s immune system. Unless its treated with antiviral drugs, it can develop into AIDS, a potentially life-threatening illness in which the body is unable to fight off foreign infection. According to the CDC, roughly 1.2 million Americans have HIV.
“If we’re going to reduce the more than 50,000 new HIV infections in this country each year, we need to increase the available options for people,” said Ronald Johnson, vice president of AIDS United. Additional studies are needed to determine Truvada effectiveness in other subgroups, including women, Johnson added.
The FDA held a meeting on May 10th, 2012 to determine whether Truvada should be approved for people who are at risk for contracting the HIV virus.
Update:
Truvada: FDA Approves First Pill To Help Prevent HIV
Pharmacy Headquarters Blog (PharmacyHeadquarters.com) Editorial Staff Copyright 2012 – All rights reserved
