RxStrategies Clinical Insights — September 2015 Issue 1

    Welcome to the first September edition of RxStrategies Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place.


    New Drug Approval

    Xuriden™ (uridine triacetate)

    September 4, 2015 — The U.S. Food and Drug Administration approved Xuriden™ (uridine triacetate), the first FDA-approved treatment for patients with hereditary orotic aciduria. Hereditary orotic aciduria is a rare metabolic disorder, which has been reported in approximately 20 patients worldwide. Hereditary orotic aciduria is inherited from a recessive gene. The disease is due to a defective or deficient enzyme, which results in the body being unable to normally synthesize uridine, a necessary component of ribonucleic acid (RNA). Signs and symptoms of the disease include blood abnormalities (anemia, decreased white blood cell count, decreased neutrophil count), urinary tract obstructiondue to the formation of orotic acid crystals in the urinary tract, failure to thrive, and developmental delays. RxS Clinical Insight: Note Xuriden™ (uridine triacetate) has been approved with Orphan Drug status. Read more.

    Varubi™ (rolapitant)

    September 1, 2015 — The U.S. Food and Drug Administration approved Varubi™ (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi™ (rolapitant) is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic and highly emetogenic) cancer chemotherapy. Varubi™ (rolapitant) is a substance P/neurokinin-1 (NK-1) receptor antagonist. Activation of NK-1 receptors plays a central role in nausea and vomiting induced by certain cancer chemotherapies, particularly in the delayed phase. Read more.

    Repatha™ (evolocumab)

    August 27, 2015 — The U.S. Food and Drug Administration approved Repatha™ (evolocumab) injection for some patients who are unable to get their low-density lipoprotein (LDL) cholesterol under control with current treatment options. Repatha™, the second drug approved in a new class of drugs known as PCSK9 inhibitors, is approved for use in addition to diet and maximally-tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or clinical atherosclerotic cardiovascular disease, such as heart attacks or strokes, who require additional lowering of LDL cholesterol. Read more.

    Addyi™ (flibanserin)

    August 18, 2015 — The U.S. Food and Drug Administration approved Addyi™ (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s™ approval, there were no FDA-approved treatments for sexual desire disorders in men or women. Addyi™ is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, but the mechanism by which the drug improves sexual desire and related distress is not known. Addyi™ is also being approved with a Boxed Warning to highlight the risks of severe hypotension and syncope in patients who drink alcohol during treatment with Addyi™, in those who also use moderate or strong CYP3A4 inhibitors, and in those who have liver impairment.
    Read more.



    New Formulation Approval

    Durlaza™ (aspirin)

    September 8, 2015 — New Haven Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration approved Durlaza™ (aspirin), the first and only 24-hour, extended-release capsules, low-dose (162.5mg) Aspirin product for the secondary prevention of stroke and acute cardiac events, including myocardial infarction (heart attack).
    Read more.

    Synjardy® (empagliflozin/metformin hydrochloride)

    August 26, 2015 — The U.S. Food and Drug Administration approved Synjardy® (empagliflozin and metformin hydrochloride) tablets for the treatment of adults with type 2 diabetes (T2D). Synjardy® is the third product containing empagliflozin to be approved by the FDA, following Jardiance® (empagliflozin) and Glyxambi® (empagliflozin/linagliptin). Synjardy® is a combination of empagliflozin and metformin—two medicines with complementary mechanisms of action—to help control blood glucose in people with T2D. Read more.

    Keveyis™ (dichlorphenamide)

    August 7, 2015 — Taro Pharmaceutical Industries Ltd. announced the U.S. Food and Drug Administration approved Keveyis™ (dichlorphenamide) 50 mg tablets for the treatment of primary hyperkalemic and hypokalemic periodic paralysis, a group of rare hereditary disorders that cause episodes of muscle weakness or paralysis. Keveyis™ is the first medicine approved by the FDA for the treatment of primary periodic paralysis, which is estimated to affect approximately 5,000 people in the United States. RxS Clinical Insight:  Note Keveyis™ (dichlorphenamide) has been approved with Orphan Drug status. Read more.

    Spritam® (levetiracetam)

    August 3, 2015 — Aprecia Pharmaceuticals Company announced the U.S. Food and Drug Administration approved Spritam® levetiracetam for oral use as a prescription adjunctive therapy, in the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy. Spritam® utilizes Aprecia’s proprietary ZipDose® technology platform, a groundbreaking advance that uses three-dimensional printing (3DP) to produce a porous formulation that rapidly disintegrates with a sip of liquid. While 3DP has been used previously to manufacture medical devices, this approval marks the first time a drug product manufactured with this technology has been approved by the FDA. Read more.



    New Indication Approval

    Brilinta® (ticagrelor)

    September 3, 2015 — AstraZeneca announced the U.S. Food and Drug Administration approved Brilinta® (ticagrelor) tablets at a new 60mg dose, to be used in patients with a history of heart attack beyond the first year. With this expanded indication, Brilinta® is now approved to reduce the rate of cardiovascular death, myocardial infarction (MI), also known as heart attack, and stroke in patients with acute coronary syndrome (ACS) or a history of MI. Read more.

    Emend® (aprepitant)

    September 2, 2015 — Merck announced the U.S. Food and Drug Administration has approved Emend® (aprepitant) capsules, a substance P/neurokinin 1 (NK1) receptor antagonist. With this expanded indication, Emend® capsules are now approved for use in combination with other antiemetic agents, in patients 12 years of age and older and patients less than 12 years who weigh at least 30 kg (approximately 66 pounds), for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC), including high-dose cisplatin, as well as for the prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Read more.

    Edurant® (rilpivirine­)

    August 27, 2015 — The Food and Drug Administration announced the Edurant® (rilpivirine) labeling has been updated to include a new pediatric indication, and changes in the warnings, precautions and adverse reactions sections. Edurant® is now approved for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve pediatric patients from ages 12–18 years with HIV-1 RNA ≤100,000 copies/mL. Read more.

    Promacta® (eltrombopag)

    August 24, 2015 — The U. S. Food and Drug Administration approved eltrombopag (Promacta® for oral suspension, Novartis) for the treatment of thrombocytopenia in pediatric patients one year and older with chronic immune (idiopathic) thrombocytopenia (ITP), who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Read more.

    Zubsolv® (buprenorphine/naloxone)

    August 11, 2014 — Orexo AB announced the U.S. Food and Drug Administration approved Zubsolv® (buprenorphine/naloxone CIII sublingual tablet) for induction of buprenorphine maintenance therapy in patients with opioid dependence. The approval expands on the current indication for Zubsolv®, originally approved by the U.S. FDA on July 3, 2013, and is based on data from two Phase III studies, demonstrating Zubsolv® as a an effective treatment for opioid dependence with a solid safety profile. Read more.



    New Generic Approval

    Drospirenone and Ethinyl Estradiol (Yasmin®)

    Sept. 8, 2015 — Mylan N.V. announced the U.S. launch of Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.03 mg, which is the generic version of Bayer’s Yasmin® tablets. Mylan’s partner Famy Care Ltd. received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for use by women to prevent pregnancy. Read more.

    Rivastigmine transdermal system (Exelon®)

    August 31, 2015 — Alvogen has launched the first generic equivalent of Exelon® patch (rivastigmine transdermal system) in the United States. The product will be marketed by Alvogen in three strengths (4.6 mg/24 hours, 9.5 mg/24 hours, and 13.3 mg/24 hours), with Alvogen being the first filer for the 13.3 mg/24 hours strength, making it eligible for 180 days of marketing exclusivity. Read more.



    New Drug Shortage

    September 9, 2015

    August 25, 2015

    July 29, 2015



    Drug Recall Alert 

    Medistat RX Sterile Drug Products

    Septermber 10, 2015 — The FDA alerted health care professionals and patients of a voluntary recall of all non-expired drug products produced for sterile use and distributed nationwide by Medistat RX, LLC, in Foley, Alabama, due to possible contamination. During an ongoing inspection, FDA investigators and Alabama state inspectors observed significant deficiencies that raise concerns about Medistat’s ability to assure officials about the sterility of drug products that it produced. The recalled products were distributed between Nov. 1, 2014, and Sept. 3, 2015. Read more.

    Hydrochlorothiazide Tablets by Unichem Pharmaceuticals (USA), Inc.

    July 31, 2015 — Unichem Pharmaceuticals (USA), Inc. (Unichem) is voluntarily recalling one lot of Hydrochlorothiazide Tablets (25 mg 1000-count bottle) to the consumer level. This recall has been initiated as a precautionary measure due to the identification of a Clopidogrel tablet found in a bottle of the product. Read more.



    Drug Safety Alert 

    Invokana® and Invokamet® (canagliflozin)

    September 10, 2015 — The FDA has strengthened the warning for the type 2 diabetes medicine canagliflozin (Invokana®, Invokamet®) related to the increased risk of bone fractures, and added new information about decreased bone mineral density. To address these safety concerns, the FDA added a new warning and precaution, and revised the adverse reactions section of the Invokana® and Invokamet® drug labels. Read more.

    DPP-4 Inhibitors for Type 2 Diabetes

    August 28, 2015 — The U.S. Food and Drug Administration warns the type 2 diabetes medicines sitagliptin, saxagliptin, linagliptin and alogliptin may cause joint pain that can be severe and disabling. FDA has added a new warning and precaution about this risk to the labels of all medicines in this drug class, called dipeptidyl peptidase-4 (DPP-4) inhibitors. Read more.

    Picato® (ingenol mebutate) Gel

    August 21, 2015 — The U.S. Food and Drug Administration warns about reports of severe allergic reactions and herpes zoster (shingles) associated with the use of Picato gel (ingenol mebutate). The FDA received reports of cases involving severe eye injuries and skin reactions associated with the application of Picato gel. Some cases were associated with Picato gel not being used according to the instructions for use on the label. Read more.

    Compounded Drugs Stored in Becton-Dickinson (BD) 3ml and 5ml Syringes

    August 18, 2015 — The U.S. Food and Drug Administration warns health care professionals not to administer to patients compounded or repackaged drugs that have been stored in 3ml and 5ml syringes manufactured by Becton-Dickinson (BD), unless there is no suitable alternative available. Preliminary information indicates that drugs stored in these syringes may lose potency over a period of time, due to a possible interaction with the rubber stopper in the syringe. Read more.

    Gilenya® (fingolimod)

    August 4, 2015 — The U.S. Food and Drug Administration warns that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya® (fingolimod) for multiple sclerosis (MS). These are the first cases of PML reported in patients taking Gilenya®, who had not been previously treated with an immunosuppressant drug for MS or any other medical condition.
    Read more.

    Brintellix® (vortioxetine) and Brilinta® (ticagrelor)

    July 30, 2015 — The FDA warns health care professionals and patients that reports of confusion between the antidepressant Brintellix and anti-blood clotting medication Brilinta® have resulted in the wrong medication being prescribed or dispensed. The FDA determined the main reason for the confusion between these two medications is the similarity of their brand (proprietary) names. None of the reports indicates that a patient ingested the wrong medication; however, reports of prescribing and dispensing errors continue. Read more.



    Clinical and Pharmacy News 

    Survey Finds 80% of Customers Would Allow Pharmacists to Access Their GP Record

    September 14, 2015 — Customers using a pharmacy vaccination service are happy for the pharmacist to be allowed access to their GP records, suggests a survey of more than 7,000 patients. The finding comes from a study conducted by researchers at the University of Nottingham, and presented at the Royal Pharmaceutical Society’s annual conference in Birmingham, Sept. 13, 2015. Read more.

    More Aggressive Control of Hypertension Is Beneficial

    September 14, 2015 — Clinicians should control hypertension much more aggressively than current guidelines suggest, to best reduce the risk for heart attack and stroke in people aged 50 years or older. That’s the message behind the potentially game-changing results of a U.S. National Institutes of Health (NIH) study released Sept. 11, 2015. Read more.

    Pharmacies Hosted at Workplaces Increase Medication Adherence

    September 14, 2015 — Employers with onsite pharmacies are seeing a return on investment in the form of increased medication adherence among their health plan members. Onsite pharmacies provide employees with a convenient option for filling discounted prescriptions that is integrated with other employer-sponsored wellness programs. Read more.

    Pharmacies Should Play a Greater Role in Providing Basic Primary Health Care

    September 13, 2015 — They can do more than dispense prescriptions, or suggest the best allergy medication. Highly educated pharmacy professionals can serve other important roles to support a patient’s healthcare needs. In fact, these professionals are equipped to help with a growing crisis in Colorado and across the country. Read more.

    Study Showing Need for Low Blood Pressure Lauded, Push to Lower Cholesterol Levels Vilified

    September 13, 2015 —In 2009, the National Institutes of Health (NIH) launched the Systolic Blood Pressure Interventional Trial, commonly known as SPRINT. Designed to be a nine-year trial involving more than 9,000 patients, aged 50 and older, and costing $114 million, investigators sought to answer the question of whether lowering systolic blood pressure (SBP, the higher of two numbers representing the pressure on the blood vessels when the heart contracts) from the recommended levels of 140 mm of Hg to below 120 mm of Hg would benefit patients at risk for heart or kidney disease.
    Read more.

    Clinical Trial Suggests New Blood Pressure Standard

    September 11, 2015 — It’s time to rethink current blood pressure guidelines. Using drugs to lower people’s systolic blood pressure, the pressure when the heart contracts, to less than 120 millimeters of mercury could cut heart attack, stroke and death rates. These are the preliminary results suggested by a clinical trial of more than 9,300 people, ages 50 and older, with high blood pressure. Read more.

    When Narrow Pharmacy Networks Work

    September 11, 2015 — CVS Health implemented a preferred pharmacy network, which lowered cost-sharing for patients and increased the amount of medication patients kept on hand, suggesting better adherence, the plan’s researchers found. Compared with the months before implementing the preferred pharmacy program, on-hand medication ratios for common drugs, like statins and hypertensives, increased by 1.65% and 1.34% in the months after implementation, and even more so in plans with 90-day supply programs. Read more.

    Reinvent Your Practice

    September 10, 2015 — How are you managing the unending chaos of prescription refills, physician calls, payer rejects and unpredictable workflow? In too many community pharmacies, the pressures are running pharmacists ragged. Instead of being proactive, they are reacting to workload pressures set by calls from patients, physician offices and payers. It doesn’t have to be this way. Read more.

    FDA Accepts for Review First NDA for a ‘Digital’ Medicine

    September 10, 2015 — The U.S. Food and Drug Administration has accepted for review what is being considered the first new drug application (NDA) for a combination product to include a sensor embedded into the tablet. The developer of the sensor—Proteus Digital Health—said it could help improve patient medication adherence, and better inform physician decision-making to tailor treatments to the patient’s needs. In the case of this new drug application, the sensor is paired with Otsuka Pharmaceutical’s FDA-approved Abilify (aripiprazole). Read more.

    The New Pharmacy: Revenue Streams, Part II

    September 10, 2015 — Want to build confidence and professional self-esteem? Start treating yourself and your family. The bodies you know best are yours and the ones in your tribe. We all have something going on: digestive issues, skin problems, joint aches, headaches, weight/conditioning, poor diets, hypertension, dyslipidemias, etc. Take on one or two of your ailments, read up on root causes (functional), get some of the alternative/complementary/functional approaches to your problems, and treat yourself. This is one of the best ways to learn to be a healer. Read more.

    A Win-Win for Pharmacy: The Rewards of Community Involvement

    September 10, 2015 — Drug abuse is a growing problem in America. Prescription drug abuse is increasing, with nearly 15,000 people dying each year from prescription drug overdoses. It isn’t just illegal drug abuse that is increasing. The use of e-cigarettes by high school students has tripled in the last year alone, and the legalization of marijuana has introduced a number of problems America hasn’t faced before. Read more.

    Pharmacists, Patients and Meds Can All Be In Synch

    September 10, 2015 — U.S. Surgeon General C. Everett Koop once said, “Drugs don’t work in patients that don’t take them.” Virtually everyone would agree that medications improve and prolong the quality of life for patients. Yet far too many people are nonadherent. According to research published earlier this year in Circulation: Cardiovascular Quality and Outcomes, four out of 10 people would be willing to accept some degree of risk of immediate death, rather than take a daily pill to prevent cardiovascular disease. Read more.

    New Cholesterol Drugs Too Pricey, Group Says

    September 9, 2015 — An independent non-profit organization that evaluates clinical and cost effectiveness of new medicines announced prices for a just-approved class of potent cholesterol lowering drugs were far too high, according to a draft report released on Sept. 8, 2015. The Food and Drug Administration has approved two brands of the injectable drugs, called PCSK9 inhibitors. Praluent, made by Regeneron Pharmaceuticals and Sanofi, will cost $14,600 for a year of treatment. Amgen Inc, set an annual price of $14,100 for its version, called Repatha. Read more.

    Volatile Generic Drug Prices Continue to Skyrocket

    September 2, 2015 – Are generic drugs affordable? For years, they were. Generic drug prices either decreased or stayed consistently lower than their brand name counterparts. Now, however, the prices of generic drugs have come under scrutiny, and become a major point of contention in U.S. health care policy conversations. Read more.

    New Guidelines for Cancer Doctors Aim to Make Sense of Gene Tests

    August 31, 2015 — The American Society of Clinical Oncology (ASCO) has issued guidelines on how cancer doctors should approach the use of new genetic tests that screen for multiple cancer genes at the same time, including counseling patients about genes whose contribution to cancer is still poorly understood. The guidelines aim to educate doctors about the risks and benefits of new genetic tests, argue for regulation to assure quality, and call for more equitable reimbursement of the cost of the tests from private and public insurers. Read more.

    Biopharmaceuticals: Pricing for Clinical Value and In-Market Risk

    August 20, 2015 — Prescription drug pricing has become a very hot topic in the last year. The public policy debate began in earnest with the market launch of Gilead’s Hepatitis C cure, Sovaldi, in 2014, sparking a Congressional investigation. Most recently, the price of Sanofi’s chronic care cholesterol lowering agent, Praluent, is a source of discussion. Sen. Ron Wyden (D-OR), the ranking member on the Senate Finance Committee, has called for reform of how Medicare and Medicaid pay for drugs.
    Read more.

    Wal-Mart’s Drug Problem: Pharmacy Business Drags On Profit

    August 18, 2015 – The world’s largest retailer has a drug problem. Wal-Mart Stores Inc. said that lower margins in its pharmacy business had emerged as a drag on profits, as it gets paid less by drug plan managers and as fewer customers pay in cash, since Obamacare has increased the ranks of insured Americans. Read more.

    Pharmacy Benefit Managers Sue Over First-of-Its Kind Arkansas Law

    August 17, 2015 — The national association representing pharmacy benefit managers is suing the state of Arkansas over a first-of-its kind law governing payments to pharmacies for generic drugs. The law requires benefit managers to pay pharmacies the amounts those pharmacies spent to buy generic drugs from wholesalers, according to invoices. Before the law’s passage, pharmacies had complained that benefit managers often paid them less for generics than what it actually cost the pharmacies to buy them from wholesalers, leaving them at a loss. Read more.