Category: Medication

Ten Breakthrough Drugs will Cost the US Nearly $50 Billion Over Ten Years

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There has been heavy debate over the high cost of prescription drugs, and an analysis by Avalere Health estimates that the federal government will spend nearly $50 billion over the next decade on ten breakthrough drugs.

The US Food and Drug Administration’s (FDA) new Breakthrough Therapy program is designed to expedite drug review periods for drugs that treat serious or life-threatening diseases where no drugs exist or that are considered more effective than treatments currently available. Drugs designated as breakthrough therapies include Gilead Sciences’ hepatitis C drug Sovaldi and Bristol-Myers Squibb’s lung and skin cancer drug Opdivo, drugs with high price tags.

The report was commissioned by America’s Health Insurance Plans (AHIP) and offers a first look at estimated state and federal spending on breakthrough drugs for certain cancers and chronic conditions. According to AHIP, these ten drugs represent a small subset of the more than 5,400 drugs in the pipeline.

The high price tags for these breakthrough drugs lead to significant increases in health care spending. Last year, spending on prescription drugs increased by 13 percent from 2013, the largest percentage in over a decade. In 2014, prescription drug spend reached a record-breaking $374 billion. Nearly half of this spending increase was a result of breakthrough therapies and specialty drugs.

Among these ten breakthrough drugs over the next decade, Medicare would absorb the largest expense at $31.3 billion. This will be followed by Medicaid with an estimated spending of $15.8 billion and another $2.1 billion in spending resulting from subsidies provided through Exchange plans under the Affordable Care Act (ACA). The report notes that total US spending may exceed these numbers when accounting for spending by other government agencies, such as Veterans Affairs and Defense, costs to private sector payers, patient out-of-pocket costs, and the significant spending increases associated with off-label use.

These new, innovative drugs offer significant promise for patients with serious health conditions, however the price that comes with these drugs often make treating large patient populations unsustainable.

Often times, breakthrough therapies have a period of market exclusivity, which can last for several years. Because of the lack of competition, drugmakers may significantly markup the price of the drug, making it unaffordable for patients and private payers.

 

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FDA approves treatment for fat below the chin

Clinical News, Industry News, Medication, OMG, Research, Social Awareness

The U.S. Food and Drug Administration today approved Kybella (deoxycholic acid), a treatment for adults with moderate-to-severe fat below the chin, known as submental fat. Using Kybella for the treatment of fat outside of the submental area is not approved and is not recommended.

Kybella is identical to the deoxycholic acid that is produced in the body. Deoxycholic acid produced in the body helps the body absorb fats. Kybella is a cytolytic drug, which when injected into tissue physically destroys the cell membrane. When properly injected into submental fat, the drug destroys fat cells; however, it can also destroy other types of cells, such as skin cells, if it is inadvertently injected into the skin.

“Treatment with Kybella should only be provided by a licensed health care professional, and patients should fully understand the risks associated with use of the drug before considering treatment,” said Amy G. Egan, M.D., M.P.H., deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “It is important to remember that Kybella is only approved for the treatment of fat occurring below the chin, and it is not known if Kybella is safe or effective for treatment outside of this area.”

Kybella is administered as an injection into the fat tissue in the submental area. Patients may receive up to 50 injections in a single treatment, with up to six single treatments administered no less than one month apart. Kybella is being provided in single patient use vials and should not be diluted or mixed with any other compounds.

The safety and effectiveness of Kybella for treatment of submental fat were established in two clinical trials which enrolled 1,022 adult participants with moderate or severe submental fat. Participants were randomly assigned to receive Kybella or a placebo for up to six treatments. The results showed that reductions in submental fat were observed more frequently in participants who received Kybella versus placebo.

Kybella can cause serious side effects, including nerve injury in the jaw that can cause an uneven smile or facial muscle weakness, and trouble swallowing. The most common side effects of Kybella include swelling, bruising, pain, numbness, redness and areas of hardness in the treatment area.

Kybella should not be used outside of the submental area, and it should not be used if there is an infection at the injection site. Caution should also be used in patients who have had prior surgical or aesthetic treatment of the submental area.

Kybella is being distributed in a dispensing pack that has a unique hologram on the vial label. If there is no hologram, do not use the product.

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FDA approves two therapies to treat IBS-D

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The U.S. Food and Drug Administration today approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments, manufactured by two different companies, for irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.

According to the National Institutes of Health, patients with irritable bowel syndrome (IBS) experience a number of signs and symptoms, including pain or discomfort in the abdomen and changes in bowel movement patterns. Studies estimate that IBS affects 10 to 15 percent of adults in the United States. IBS-D is a subtype characterized mainly by loose or watery stools at least 25 percent of the time.

“For some people, IBS can be quite disabling, and no one medication works for all patients suffering from this gastrointestinal disorder,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research. “The approval of two new therapies underscores the FDA’s commitment to providing additional treatment options for IBS patients and their doctors.”

Viberzi, which contains a new active ingredient, is taken orally twice daily with food. Viberzi activates receptors in the nervous system that can lessen bowel contractions. Viberzi is intended to treat adults with IBS-D.

Xifaxan can be taken orally three times a day for 14 days, for the treatment of abdominal pain and diarrhea in patients with IBS-D. Patients who experience a recurrence of symptoms can be retreated with a 14 day treatment course, up to two times. Xifaxan, an antibiotic derived from rifampin, was previously approved as treatment for travelers’ diarrhea caused by E. coli and for reduction of the risk in adult patients of recurring overt hepatic encephalopathy, the changes in brain function that occur when the liver is unable to remove toxins from the blood. The exact mechanism of action of Xifaxan for treatment of IBS-D is not known, but is thought to be related to changes in the bacterial content in the gastrointestinal tract.

The safety and effectiveness of Viberzi for treatment of IBS-D were established in two double-blind, placebo-controlled clinical trials in which 2,425 patients were randomly assigned to receive Viberzi or placebo. Results showed Viberzi was more effective in simultaneously reducing abdominal pain and improving stool consistency than placebo over 26 weeks of treatment.

The safety and effectiveness of Xifaxan for treatment of IBS-D were established in three double-blind, placebo-controlled trials. In the first two trials, 1,258 patients were randomly assigned to receive Xifaxan or placebo for 14 days, and then followed for a 10-week treatment-free period. More Xifaxan-treated patients reported improvements in abdominal pain and stool consistency than those on placebo. A third trial evaluated repeat courses of Xifaxan, because patients with IBS-D can develop recurrent signs and symptoms after a single treatment course of Xifaxan. A total of 636 patients with recurrence were randomized to receive either Xifaxan or placebo for two additional 14-day courses separated by 10 weeks. More patients treated with Xifaxan than placebo were responders in abdominal pain and stool consistency in this phase of the study.

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Two therapies to treat IBS-D

Clinical News, Industry News, Medication, Social Awareness, Tips

The U.S FDA today approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments, manufactured by two different companies, for irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.

According to the National Institutes of Health, patients with irritable bowel syndrome (IBS) experience a number of signs and symptoms, including pain or discomfort in the abdomen and changes in bowel movement patterns. Studies estimate that IBS affects 10 to 15 percent of adults in the United States. IBS-D is a subtype characterized mainly by loose or watery stools at least 25 percent of the time.

“For some people, IBS can be quite disabling, and no one medication works for all patients suffering from this gastrointestinal disorder,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research. “The approval of two new therapies underscores the FDA’s commitment to providing additional treatment options for IBS patients and their doctors.”

Viberzi, which contains a new active ingredient, is taken orally twice daily with food. Viberzi activates receptors in the nervous system that can lessen bowel contractions. Viberzi is intended to treat adults with IBS-D.

Xifaxan can be taken orally three times a day for 14 days, for the treatment of abdominal pain and diarrhea in patients with IBS-D. Patients who experience a recurrence of symptoms can be retreated with a 14 day treatment course, up to two times. Xifaxan, an antibiotic derived from rifampin, was previously approved as treatment for travelers’ diarrhea caused by E. coli and for reduction of the risk in adult patients of recurring overt hepatic encephalopathy, the changes in brain function that occur when the liver is unable to remove toxins from the blood. The exact mechanism of action of Xifaxan for treatment of IBS-D is not known, but is thought to be related to changes in the bacterial content in the gastrointestinal tract.

The safety and effectiveness of Viberzi for treatment of IBS-D were established in two double-blind, placebo-controlled clinical trials in which 2,425 patients were randomly assigned to receive Viberzi or placebo. Results showed Viberzi was more effective in simultaneously reducing abdominal pain and improving stool consistency than placebo over 26 weeks of treatment.

The safety and effectiveness of Xifaxan for treatment of IBS-D were established in three double-blind, placebo-controlled trials. In the first two trials, 1,258 patients were randomly assigned to receive Xifaxan or placebo for 14 days, and then followed for a 10-week treatment-free period. More Xifaxan-treated patients reported improvements in abdominal pain and stool consistency than those on placebo. A third trial evaluated repeat courses of Xifaxan, because patients with IBS-D can develop recurrent signs and symptoms after a single treatment course of Xifaxan. A total of 636 patients with recurrence were randomized to receive either Xifaxan or placebo for two additional 14-day courses separated by 10 weeks. More patients treated with Xifaxan than placebo were responders in abdominal pain and stool consistency in this phase of the study.

The most common side effects in patients treated with Viberzi include constipation, nausea and abdominal pain. The most serious known risk associated with Viberzi is the risk of spasm in the sphincter of Oddi, the smooth muscle that surrounds the end portion of the common bile and pancreatic ducts, which can result in pancreatitis. Viberzi should not be used in patients with a history of bile duct obstruction, pancreatitis, severe liver impairment, or severe constipation, and in patients who drink more than three alcoholic beverages per day.

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Fecal incontinence device for women

Medication, Recruitment News, Research, Social Awareness

Fecal incontinence is the inability to control bowel movements and is a common problem, especially among older adults. The most common cause of FI is damage to the muscles around the anus (anal sphincters). Vaginal childbirth can damage the anal sphincters or their nerves, which is why FI impacts women about twice as often as men.

“Current treatment options for fecal incontinence include drugs, dietary changes, exercise, and surgery,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “The Eclipse System provides an additional treatment option for women who suffer from this condition.”

The Eclipse System is intended to treat FI in women 18 to 75 years old who have had four or more FI episodes in a two-week period. The device includes an inflatable balloon, which is placed in the vagina. Upon inflation, the balloon exerts pressure through the vaginal wall onto the rectal area, thereby reducing the number of FI episodes. The device is initially fitted and inflated by a clinician (with the use of a pump) and after proper fitting, the patient can inflate and deflate the device at home as needed. The device should be removed periodically for cleaning.

The FDA reviewed data for the Eclipse System through the de novo classification process, a regulatory pathway for some low-to-moderate risk medical devices that are not substantially equivalent to a legally marketed device.

The FDA granted the de novo request based on non-clinical testing as well as a clinical trial of 61 women with FI treated with the device. The trial showed that after one month almost 80 percent of women in the study experienced a 50 percent decrease in the number of FI episodes while using the device, as compared to baseline.

Adverse events associated with the device included pelvic cramping and discomfort; pelvic pain; vaginal abrasion, redness, or discharge; and urinary incontinence. All device-related adverse events were mild or moderate, and none required any significant intervention (i.e., no surgeries were needed).

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New, non-surgical temporary balloon to treat obesity

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The U.S. Food and Drug Administration today approved a new balloon device to treat obesity without the need for invasive surgery. The ReShape Integrated Dual Balloon System (ReShape Dual Balloon) is intended to facilitate weight loss in obese adult patients. The device likely works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood.

The ReShape Dual Balloon device is delivered into the stomach via the mouth through a minimally invasive endoscopic procedure. The outpatient procedure usually takes less than 30 minutes while a patient is under mild sedation. Once in place, the balloon device is inflated with a sterile solution, which takes up room in the stomach.

The device does not change or alter the stomach’s natural anatomy. Patients are advised to follow a medically supervised diet and exercise plan to augment their weight loss efforts while using the ReShape Dual Balloon and to maintain their weight loss following its removal. It is meant to be temporary and should be removed six months after it is inserted.

“For those with obesity, significant weight loss and maintenance of that weight loss often requires a combination of solutions including efforts to improve diet and exercise habits,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This new balloon device provides doctors and patients with a new non-surgical option that can be quickly implanted, is non-permanent, and can be easily removed.”

 

The ReShape Dual Balloon was studied in a clinical trial with 326 obese participants aged 22 to 60 (with a BMI of 30 kg/m2 to 40 kg/m2) who had at least one obesity-related health condition. In the study, 187 individuals randomly selected to receive the ReShape Dual Balloon lost 14.3 pounds on average (6.8 percent of their total body weight) when the device was removed at six months, while the control group (who underwent an endoscopic procedure but were not given the device) lost an average of 7.2 pounds (3.3 percent of their total body weight).

Six months following the device removal, patients treated with the ReShape Dual Balloon device kept off an average of 9.9 pounds of the 14.3 pounds they lost.

Potential side effects for the procedure include headache, muscle pain, and nausea from the sedation and procedure; in rare cases, severe allergic reaction, heart attack, esophageal tear, infection, and breathing difficulties can occur. Once the device is placed in the stomach, patients may experience vomiting, nausea, abdominal pain, gastric ulcers, and feelings of indigestion.

 

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New Drug for treatment of Diabetes

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he U.S. Food and Drug Administration today approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus.

 

“Long-acting insulins play an essential role in the treatment of patients with type-1 diabetes and in patients with type-2 diabetes with advanced disease,” said Jean-Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “The FDA remains committed to support the development of innovative therapies for the treatment of diabetes.”

Tresiba is a long-acting insulin analog indicated to improve glycemic control in adults with type 1 and 2 diabetes mellitus. Dosing of Tresiba should be individualized based on the patient’s needs. Tresiba is administered subcutaneously once daily at any time of day.

The efficacy and safety of Tresiba used in combination with mealtime insulin for the treatment of patients with type-1 diabetes were evaluated in two 26-week and one 52-week active-controlled clinical trials involving 1,102 participants exposed to Tresiba. The efficacy and safety of Tresiba used in combination with mealtime insulin or used as add-on to common background oral antidiabetic drugs for the treatment of patients with type-2 diabetes were evaluated in four 26-week and two 52-week active-controlled clinical trials involving 2,702 participants exposed to Tresiba. In participants with type 1 and 2 diabetes who had inadequate blood sugar control at trial entry, treatment with Tresiba provided reductions in HbA1c (hemoglobin A1c or glycosylated hemoglobin, a measure of blood sugar control) in line with reductions achieved with other, previously approved long-acting insulin.

Ryzodeg 70/30 is a mixture of insulin degludec, a long-acting insulin analog, and insulin aspart, a rapid-acting human insulin analog. It is indicated to improve glycemic control in adults with diabetes mellitus. 

The efficacy and safety of Ryzodeg 70/30 used in combination with mealtime insulin for the treatment of patients with type 1 diabetes were evaluated in one 26-week active controlled clinical trial involving 362 participants exposed to Ryzodeg 70/30. The efficacy and safety of Ryzodeg 70/30 administered once or twice daily for the treatment of patients with type 2 diabetes were evaluated in four active controlled 26-week clinical trials involving 998 participants exposed to Ryzodeg 70/30. In participants with type 1 and 2 diabetes who had inadequate blood sugar control at trial entry, treatment with Ryzodeg 70/30 provided reductions in HbA1c equivalent to reductions achieved with other, previously approved long-acting or pre-mixed insulin.

Tresiba and Ryzodeg should not be used in those who have increased ketones in their blood or urine (diabetic ketoacidosis). Patients or caregivers should monitor blood glucose in all patients treated with insulin. Insulin regimens should be modified cautiously and only under medical supervision. Tresiba and Ryzodeg may cause low blood sugar (hypoglycemia), which can be life-threatening. Patients should be monitored more closely with changes to insulin dosage, co-administration of other glucose-lowering medications, meal pattern, physical activity, and in patients with renal impairment or hepatic impairment orhypoglycemia unawareness.

Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin.

The most common adverse reactions associated with Tresiba and Ryzodeg in clinical trials were hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site (lipodystrophy), itching, rash, edema, and weight gain.

Tresiba and Ryzodeg are manufactured by Novo Nordisk in Plainsboro, New Jersey.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Federal judge enters permanent injunction against Wisconsin dietary supplement manufacturers

Industry News, Medication

Three dietary supplement companies, under the same ownership and located in Wautoma, Wisconsin, will not be allowed to manufacture or sell dietary supplement products until FDA has determined that the businesses are in compliance with federal manufacturing regulations and other requirements, according to a federal court order signed Aug. 4, 2015.

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