Breast Cancer Drug Duo Helps Metastatic Breast Cancer Patients
August 13, 2012 § Leave a Comment
Breast Cancer Drug Duo Helps Metastatic Breast Cancer Patients
Combining two cancer drugs works better than one to improve survival of metastatic breast cancer (HR-positive type) in older women, according to a study published in the New England Journal of Medicine.
The drug duo consists of anastrozole (Arimidex) and fulvestrant (Faslodex), which are presently used individually to treat breast cancer.
“With the combination, there is a 20 percent improvement in progression-free survival and a 19 percent improvement in overall survival,” said researcher Dr. Rita Mehta, an associate professor of health sciences at the University of California, Irvine, School of Medicine.
In other words, those who were treated with the drug combo gained six months. The women on the drug combination treatment lived a median of 47.7 months compared to a median of 41.3 months on patients treated with one drug. Additionally, the disease took 15 months and 13.5 months to progress on the combination drugs and solo-drugs, respectively.
The study consisted of approximately 700 postmenopausal women who were treated to Arimidex only or a combination of both drugs. All women were diagnosed with hormone receptor-positive breast cancer, which is the type that accounts for over half of all cases of breast cancer.
Arimidex is an oral drug, which works by decreasing the amount of estrogen the body produces. Faslodex is an injectable drug, which works by blocking estrogen’s action on cancer cells.
The study took place over five years and was supported by National Cancer Institute and AstraZeneca, which produces both Arimidex and Faslodex.
Pharmacy Headquarters Blog (PharmacyHeadquarters.com) Editorial Staff Copyright 2012 – All rights reserved
Good News for Allergy and Asthma Sufferers! First Generic Singulair Approved by the FDA
August 13, 2012 § Leave a Comment
Good News for Allergy and Asthma Sufferers! First Generic Singulair Approved by the FDA
The U.S. Food and Drug Administration (FDA) has approved the first generic version of Singulair (montelukast sodium).
Montelukast is to be used in children and adults to prevent wheezing, coughing, chest tightness, and difficulty breathing caused by asthma. It can also be used to treat these symptoms caused by seasonal allergies, year-round allergies, and allergic rhinitis (a condition that causes a runny, itchy, or stuffy nose, along with bouts of sneezing). Additionally, this generic version of Singular is used to prevent a condition called bronchospasm, which makes breathing difficult.
“For people who suffer from chronic health conditions such as asthma and allergies, it is important to have effective and affordable treatment options,” said Gregory P. Geba, M.D., M.P.H., director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research. “The generic products approved today will expand those options for patients,” Geba said.
Unlike many allergy drugs which block the histamine protein, Singulair blocks the proteins — called leukotrienes — that cause inflammation.
It’s important to note that montelukast sodium isn’t to be used in cases of a sudden onset of asthma symptoms, warns the FDA. As seen in clinical trial of Singulair, the most common side effects were headache, fever, ear ache, flu, cough, sore throat, runny nose, diarrhea, and fever. More serious side effects include hallucinations, depression, mood changes, extremities numbness, behavioral changes, and upper respiratory infection.
The brand-name, Singular, which is manufactured by Merck & Co., obtained approval from the FDA in 1998. The asthma and allergy medication Singulair is Merck & Co.’s best-selling drug, reportedly bringing in $5 billion annually.
Approval to manufacture the generic chewable tablets, generic tablets, or both were given to 10 pharmaceutical companies.
Pharmacy Headquarters Blog (PharmacyHeadquarters.com) Editorial Staff Copyright 2012 – All rights reserved
Got Dry Eyes? Take a Look at the New FDA-Approved Technology Helps Ease Dry Eye
August 13, 2012 § Leave a Comment
Got Dry Eyes? Take a Look at the New FDA-Approved Technology Helps Ease Dry Eye
Millions of Americans suffer from dry eye syndrome, or evaporative dry eye. Some estimate say as many 23 million people in the United States experience symptoms of dry eye.
To relieve their symptoms, people have turned to over-the-counter drops, artificial tears, or prescription medications, like Restasis (Cyclosporin). Now, a new breakthrough treatment offers relief for dry eye sufferers who don’t obtain relief from the aforementioned methods.
LipiFlow is a FDA-approved technology that promises dry eye relief in a single, painless, 12-minute treatment. During the non-invasive treatment, the glands of the eyelid are heated as well as massaged in order to open eyelid blockages. Some patients say it is comparable to a spa treatment for dry eyes.
Within a few days or weeks, the majority of dry eye patients see improvement in their symptoms, including more stable vision and greater eye comfort. Most of the patients who use LipiFlow have symptom improvement for up to a year, or even longer.
“Evaporative Dry Eye has always been a challenge to treat, and traditional treatments provide very limited relief” says Dr. Alan Glazier, CEO of Shady Grove Eye and Vision Care. Our patients suffer with no good options for relief, and our mission is to provide patients’ their desired outcomes. Without LipiFlow, we couldn’t do that, so the decision to be first in the region to implement the technology was a no-brainer. We have created a refuge for our patients who so desperately seek relief from this debilitating condition and can’t find it elsewhere,” Glazier said.
Findings of a LipiFlow study revealed that 79 percent of the study participants reported dry eye symptom improvement within four weeks, and continued to improve thereafter. As patient symptoms continued to improve, the were able to decrease their use of eye drops. Months later, for some, no drops were needed.
Pharmacy Headquarters Blog (PharmacyHeadquarters.com) Editorial Staff Copyright 2012 – All rights reserved
Types of Insulin for Diabetes Treatment: Long-Acting Insulin (Series: 1 of 5)
August 7, 2012 § Leave a Comment
Types of Insulin for Diabetes Treatment: Long-Acting Insulin (Series: 1 of 5)
Today’s post is the first in a five part series on the types of insulin for diabetes treatment. For the first post in the series, we’re focusing on long-lasting insulin. Other posts in the series will feature rapid-acting insulin, short-acting insulin, intermediate-acting insulin, and pre-mixed insulin — so stay tuned!
Your physician will work with you to prescribe the best type of insulin for you and for your diabetes management. The right type may depend on a number of factors, including your body’s response to insulin, your lifestyle choices, how often you check your blood sugar, and your age. It may take trial-and-error to find the best type of insulin for you.
Now that we got the background out of the way, let’s talk about long-acting insulin.
Long-acting insulin, also referred to as long-lasting insulin, typically covers insulin needs for approximately one full day. Long-acting insulin’s begins to work within 30 minutes to 2 hours of injection. They are sometimes combined with short-acting, or rapid, insulin.
Long-lasting insulin works continuously, some without having a peak. In this way, it mimics the natural insulin-secretion of the pancreas. Because there is a constant delivery of insulin, long-acting insulin can reduce the risk of low blood sugar, or hypoglycemia.
Examples of long-lasting insulin include Lantus (Insulin Glargine) and Levemir (Insulin Detemir). For convenience, these types of insulin injectables are available in a Flex Pen.
Regardless of which long-lasting insulin you and your doctor choose to use to manage your diabetes, it’s important to adhere to a healthy lifestyle, which includes exercise and eating a diabetes-friendly diet.
Pharmacy Headquarters Blog (PharmacyHeadquarters.com) Editorial Staff Copyright 2012 – All rights reserved
Got Asthma? You’re Not Alone. It’s Also Common Among Olympic Athletes.
August 7, 2012 § Leave a Comment
Got Asthma? You’re Not Alone. It’s Also Common Among Olympic Athletes.
Affecting roughly 8 percent of Olympic athletics, asthma, along with airway hyper-responsiveness, are the most common chronic conditions these fierce competitors face, according to a new study out of Australia.
What’s the reason for the common link between asthma and Olympiads? Australian researcher Kenneth Fitch suggests it may be linked to the intense training these athletes are subjected too. In particular, the link seems to be associated with athletes who participate in endurance sports, like swimming, cycling, or track, or winter sports, such as cross-country skiing. Inhaling cold air can contribute to airway damage, explains Fitch.
“Inhaling polluted or cold air is considered an important factor which might explain the cause in some sports, but not in all,” explained Fitch of the University of Western Australia. “The quality of inhaled air could be harmful to the airways, but does not cause the same effect in all sports,” he further commented.
In coming up with his findings, Fitch tallied up the number of athletes from five Olympic games held between 2002 and 2010 who has airway hyper-responsiveness and asthma. He identified the athletes by counting the utilization of inhaled beta-2 agonists.
Commonly used by stellar athletes, inhaled beta-2 agonists are an anti-asthmatic drug, which causes muscle relaxation and dilation of bronchial passages.
Fitch also noticed that asthmatic athletes have beaten their opponents routinely. However, he added that there is no real proof that their asthma treatment improved their athletic performance. Rather, he proposed that these athletes may train harder, which may explain why they develop asthma.
Fitch’s research is published on line in the British Journal of Sports Medicine.
Pharmacy Headquarters Blog (PharmacyHeadquarters.com) Editorial Staff Copyright 2012 – All rights reserved
Rayos: New FDA-Approved Morning Pain Relief Pill for Rheumatoid Arthritis
August 7, 2012 § Leave a Comment
Rayos: New FDA-Approved Morning Pain Relief Pill for Rheumatoid Arthritis
The FDA gave its stamp of approval on Rayos, a delayed-release version of low-dosage corticosteroid prednisone, which is a common pain-relieving steroid. Rayos is indicated for a wide range of disorders, including rheumatoid arthritis, psoriatic arthritis, chronic obstructive pulmonary disease, and asthma.
Rayos is meant to be taken by patients at night — before they go to bed. As part of its delayed-release formulation, the drug has an outer layer that slowly dissolves in the digestive system. After about four hours of taking the drug, the active-ingredient prednisone will be released when patients need it the most. Many rheumatoid arthritis patients suffer from overnight pain or morning stiffness, and Rayos is stands to help patients on both of these fronts.
The drug will be available in 1 mg, 2 mg and 5 mg doses.
Rayos is manufactured by Deerfield, IL-based Horizon Pharm, who had its Duexis approved by the FDA last year.
The FDA based its approval on information from the Circadian Administration of Prednisone in RA trials, called the CAPRA-1 and 2. The overall safety of Rayos was supported by the CAPRA-1 trial while significant improvement in criteria used to measure joints were seen in moderate to severe RA patients who were treated with Rayos.
“Our initial focus will be on the launch of Rayos in rheumatologic diseases such as RA and polymyalgia rheumatica in the fourth quarter of this year. Based on the extent of the approved indications, we will be developing a broader commercial strategy to expand the opportunity for Rayos in key IL-6 mediated diseases, including asthma and COPD,” said Timothy P. Walbert, chair, president and CEO of Horizon Pharma.
Pharmacy Headquarters Blog (PharmacyHeadquarters.com) Editorial Staff Copyright 2012 – All rights reserved
Nightime Snack Attack
August 3, 2012 § Leave a Comment
Nightime Snack Attack
What do you think are the worst nighttime snacks?
Many experts suggest avoiding eating within 2-3 hours before going to bed. But besides this time factor, certain foods can disrupt the quality of your sleep. According to Dr. Oz, these are:
- Sugary cereals – can cause a spike in your blood sugar.
- Red meats – contain high amounts of protein and fat, making them sit in your stomach longer.
- Spicy food – can stimulate your senses
- Citrus foods – while certainly good for you, when consumed at night time can lead to indigestion or heartburn
- Foods and beverages with caffeine – coffee, tea, and even dark chocolate when taken before bed can make it more difficult to fall asleep and stay asleep.
What do you think are good nighttime stacks?
If you guessed any of the below, you are right!
- Greek yogurt combined with a half a banana and a few blueberries
- Banana with some peanut butter
- Oatmeal and low fat milk
- Green apple with almond butter
- Hard boiled egg
Of course there are others, but keep in mind that a snack before bed should be limited to no more than 200 calories. Happy dreams! Fun one!!
Pharmacy Headquarters Blog (PharmacyHeadquarters.com) Editorial Staff Copyright 2012 – All rights reserved
Breathing Easier! Smoker’s cough (COPD) relieved by Tudorza Pressair
July 30, 2012 § Leave a Comment
Breathing Easier! Smoker’s cough (COPD) relieved by Tudorza Pressair
Forest Laboratories Inc’s inhaled dry powder treatment for smoker’s cough, commonly called COPD, has been approved by the U.S. Food and Drug Administration (FDA).
Named Tudorza Pressair (aclidinium bromide), the drug improves airflow through relaxation of the muscles surrounding the large airways of the lungs.
The twice-daily drug is indicated to treat the symptoms of chronic obstructive pulmonary disease (COPD), which is a serious lung disease that causes difficulty in breathing; it’s often caused by cigarette smoking. Currently, the inhaler is the only FDA-approved inhaler for the long-term maintenance of COPD in adults 18 years and older. It’s not to be considered for use as a rescue medication for sudden breathing problems, however.
In the United States, COPD is the fourth leading cause of death, according to the FDA.
“COPD is a serious disease that gets worse over time,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in FDA’s Center for Drug Evaluation and Research. “The availability of long-term maintenance drugs for COPD provides additional treatment options for the millions of people who suffer with this debilitating disease.”
COPD is a catch-all term used for chronic lung diseases including chronic bronchitis and emphysema. The symptoms of COPD consist of a chronic cough, excessive phlegm, shortness of breath and tightness in the chest.
The FDA based its safety and efficacy approval of Tudorza Pressair on three randomized, placebo-controlled studies, which included over 1,270 people inflicted with COPD. All study participants had a history of smoking for day years of at least one pack of cigarettes per day. Study participants who used Tudorza Pressair displayed improvement in their lung functioning.
Paradoxical bronchospasm, new or exascerbated urinary retention, or new or worsened increased eye pressure (acute narrow-angle glaucoma) are listed as serious side effects. Common side effects include cough, nasal passage inflammation, and headache.
Pharmacy Headquarters Blog (PharmacyHeadquarters.com) Editorial Staff Copyright 2012 – All rights reserved
Help for Post Shingles Pain! Horizant delivers unexpected relief
July 30, 2012 § Leave a Comment
Help for Post Shingles Pain! Horizant delivers unexpected relief
Horizant (gabapentin enacarbil), a drug approved by the FDA in April of 2011 for the treatment of restless leg syndrome (RLS) has now been approved by the FDA for a new use: post-shingles pain.
Postherpetic neuralgia (PHN) is a common and excruciating painful complication of a bout with shingles, which is less commonly known as herpes zoster. PHN can lead to disability in some people.
Experts say that roughly one million people in the United States develop shingles annually. Of these people, approximately 10 percent will later develop the painful PHN condition.
Shingles involves an adulthood reactivation of a chickenpox infection from childhood. After a chickenpox attack, the virus lies dormant. However, it can reappear later in life. It’s more often seen in people with weakened immune systems.
A tingling or burning pain or itch is the first sign of shingles. The rash appears in rows and follows the path of some nerves. It’s generally seen on the scalp, face, neck, and trunk, but typically stops at the body’s midline.
In areas affected by the shingles, PHN causes pain, often in the area of the torso. The pain can last for months or years after the original infection.
Researchers aren’t certain on how Horizant works to thwart post-shingles pain, but studies have revealed that gabapentin can help reduce nerve-related pain. Horizant, which was developed by XenoPort Inc. and marketed by GlaxoSmithKline, is a slightly less active type of gabapentin, an antiepileptic drug.
Common side effects of Horizant include headaches, sleepiness, and dizziness.
Pharmacy Headquarters Blog (PharmacyHeadquarters.com) Editorial Staff Copyright 2012 – All rights reserved
Fish Oils get Fancy! FDA approves Vascepa for heart care
July 30, 2012 § Leave a Comment
Fish Oils get Fancy! FDA approves Vascepa for heart care
U.S. Food and Drug Administration (FDA) has approved Vascepa (icosapent ethyl), a new prescription-based formulation of fish oils to treat very high levels of triglycerides, or very high levels of fats in the blood stream.
Vascepa, in a 1 gram oral capsule, is indicated as a treatment method as supplement to diet to help reduce triglyceride levels in adults with severe hypertriglyceridemia. Along with cholesterol, triglycerides is a blood fat that contributes to cardiovascular disease. Vascepa contains omega-3 fatty acids, which are contained in fish oil and thought to have heart-protecting properties.
Vascepa, formerly called AMR101, is manufactured by Amarin Corporation plc, a biopharmaceutical company headquartered in Bedminster, New Jersey that focuses on developing therapeutics to improve heart health. Vascepa is Amarin Corporation’s first FDA-approved medication.
“FDA approval of Vascepa represents the introduction of an important new treatment option for patients with severe hypertriglyceridemia. In Amarin’s MARINE clinical trial, Vascepa demonstrated a statistically significant placebo-adjusted reduction in levels of triglycerides without elevation in levels of LDL-C, commonly referred to as ‘bad cholesterol,’” stated Joseph Zakrzewski, Chairman and CEO of Amarin.
Approximately 4 million Unites States adults have severe hypertriglyceridemia ( > 500 mg/dL), according to Amarin.
With Vascepa’s FDA approval, it becomes a competitor for high-selling heart pill Lovaza, manufactured by GlaxoSmithKline Plc.
Amarin hopes to commercially launch Vascepa within the first three months of 2013.
Pharmacy Headquarters Blog (PharmacyHeadquarters.com) Editorial Staff Copyright 2012 – All rights reserved
