wellinformed APRIL 2016

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1 wellinformed APRIL 2016 New FDA-Approved Drugs The following drug products were recently approved by the U.S. Food and Drug Administration (FDA): Zemplar Paricalcitol Parathyroid hormone Sernivo Betamethasone Dipropionate Mild to moderate plaque psoriasis Briviact Brivaracetam Partial onset seizures Zemplar is an intravaneous (IV) injection and an active form of vitamin D used to prevent and treat secondary hyperparathyroidism (increased parathyroid hormone levels) in patients with Stage 3 or Stage 4 chronic kidney disease and in Stage 5 patients on dialysis. Paricalcitol binds to the vitamin D receptor to lower parathyroid hormone (PTH) levels. In clinical trials, patients treated with paricalcitol achieved an average PTH reduction of 30% in six weeks. Sernivo Spray is a corticosteroid indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. Sernivo Spray contains % of the corticosteroid betamethasone dipropionate (equivalent to 0.05% betamethasone). Two clinical trials were conducted in subjects aged 18 years and older with moderate plaque psoriasis to evaluate the safety and effi cacy of Sernivo Spray. In both trials, randomized subjects applied Sernivo Spray to the affected areas twice daily for 28 days. At Day 29 in Studies 1 and 2, Sernivo achieved treatment success rates of 42.7% and 34.5% compared to placebo rates of 11.7% and 13.6%. Briviact is a selective, high-affinity synaptic vesicle protein 2A ligand and analog of levetiracetam indicated for the treatment of partial-onset seizures in patients age 16 years and older with epilepsy. Epilepsy is a brain disorder that causes people to have recurring seizures. Approximately 5.1 million people in the United States have a history of epilepsy and approximately 2.9 million people in the United States have active epilepsy. In clinical trials, brivaracetam was well tolerated. The results of this study suggest that concomitant brivaracetam at a dose of 50 mg/day results in signifi cant reductions in seizure frequency as compared to placebo. Nasonex Now Available The U.S. Food and Drug Administration (FDA) approved the fi rst generic version of Nasonex nasal spray (mometasone furoate monohydrate). Mometasone furoate is a nasal corticosteroid that works by reducing swelling (infl ammation) in the nasal passages. The nasal spray is approved for the treatment of nasal symptoms of seasonal allergic and perennial allergic rhinitis, in children and adults that are two years of age or older. Mometasone furoate spray is also indicated for the prevention of nasal symptoms caused by seasonal allergies in patients who are at least 12 years of age and for the treatment of nasal polyps in adults. Merck, the manufacturer of brand Nasonex, made approximately $955.5 million in sales of Nasonex in First generic Nasonex available. Available at: com/news/fi rst-generic-nasonex-available. Accessed April 4, GENERIC NAME: mometasone furoate nasal inhaler/spray. Available at: furoate/article.htm. Accessed April 4, HIGHLIGHTS OF PRESCRIBING INFORMATION. Available at: apotex.com/us/en/products/downloads/pil/ mome_naso_ins.pdf. Accessed April 4, (Continued on page 2)

2 New FDA-Approved Drugs (Continued from page 1) Xeljanz XR Tofacitinib Citrate Rheumatoid Arthritis Xeljanz XR is an extended-release 11 mg tablet for the once-daily treatment of moderate to severe rheumatoid arthritis (RA) in patients with an inadequate response or intolerance to methotrexate; may be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs. Xeljanz XR 11 mg administered once daily was found to be equivalent to Xeljanz 5 mg administered twice daily. Xeljanz has been shown to be effective in reducing the progression of joint damage. In clinical trials, more than half of Xeljanz patients experienced an improvement in RA symptoms at three months. In some patients, Xeljanz began to work in as early as two weeks to reduce RA joint pain and swelling. Aczone Dapsone Acne Vulgaris Aczone 7.5% gel is a new strength approved to treat acne in patients 12 years of age and older. In clinical trials, 41% of people treated with Aczone Gel had little to no acne at twelve weeks, compared to 33% in the placebo group. Aczone 5% gel was approved in TetraVisc Tetracaine Hydrdochloride Ophthalmic TetraVisc is a sterile topical ophthalmic solution used as anesthesia for the eye. TetraVisc eye drops are used to numb the eye before surgery, tests, or procedures. Odefsey Emtricitabine, Rilpivirine, Tenofovir Alafenamide HIV Odefsey is indicated for the treatment of HIV-1 infection in patients 12 years of age and older who have no antiretroviral treatment history and HIV-1 RNA levels less than or equal to 100,000 copies per ml. Odefsey is also indicated as replacement for a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per ml). Odefsey contains a new form of tenofovir that caused less kidney and bone damage in clinical trials. Complera, another HIV product from Gilead, contains the same ingredients with the previously approved form of tenofovir (tenofovir disoproxil fumarate). Cambia Diclofenac Potassium Migraine Cambia is a nonsteroidal anti-infl ammatory drug (NSAID) that reduces substances in the body that cause pain and infl ammation. Cambia is used to treat migraine headaches, with or without aura, in adults 18 years of age and older. Evomela Melphalan Cancer Evomela is indicated for the treatment of multiple myeloma patients unable to take oral medications. It is also approved, in high doses, as the first drug for pre-conditioning prior to progenitor (stem) cell transplant for multiple myeloma patients. Clinical studies demonstrated an overall response rate (ORR) with Evomela was 95% among 61 patients. Anthim Obiltoxaximab Inhalational anthrax Taltz Ixekizumab Plaque psoriasis Anthim is a high-affinity monoclonal injection indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs. Inhalation of anthrax is a life-threatening infectious disease caused by the bacterium Bacillus anthracis. Inhaled anthrax is often fatal, despite treatment with antibiotics. Animal trials demonstrated the effi cacy of Anthim following anthrax exposure. Taltz is a new specialty medication approved for use in patients with psoriasis that are candidates for systemic therapy or phototherapy. Psoriasis is a skin condition that causes patches of skin redness and fl aking. Psoriasis is an autoimmune disorder that occurs more commonly in patients with a family history of the disease, and most often begins in people between the ages of 15 and 35. Taltz product will be on both the standard and specialty PA programs. (Continued on page 3)

3 New FDA-Approved Drugs (Continued from page 2) Cinqair Reslizumab Asthma Cinqair is a monoclonal antibody indicated in patients 18 years of age and older with severe asthma that continue to have attacks despite treatment with alternative medications. Asthma is a chronic disease that causes infl ammation in the airways of the lungs. According to the Centers for Disease Control and Prevention, as of 2013, more than 22 million people in the U.S. have asthma, and there are more than 400,000 asthma-related hospitalizations each year. Cinqair is an IV infusion administered once every four weeks by a health care professional. Cinqair reduces severe asthma attacks by reducing the levels of blood eosinophils, a type of white blood cell that contributes to the development of asthma. Defi telio Defibrotide Sodium Venoocclusive disease (VOD) Defi telio is an IV injection indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT). Cambia. Available at: Defi telio Approval History. Available at: telio.html. Drugs@FDA FDA Approved Drug Products. Available at: FDA Approves Briviact (brivaracetam) to Treat Partial Onset Seizures. Available at: FDA approves Cinqair to treat severe asthma. Available at: FDA Approves Evomela for Treatment of Multiple Myeloma. Available at: FDA approves fi rst treatment for rare disease in patients who receive stem cell transplant from blood or bone marrow. Available at: Newsroom/PressAnnouncements/ucm htm. FDA Approves Gilead s HIV Tablet Odefsey, an Updated Version of Complera. Available at: FDA approves new psoriasis drug Taltz. Available at: FDA approves new treatment for inhalation anthrax. Available at: Accessed April 6, It May Be Time To Try Aczone (Dapsone) Gel 5%. Available at: paricalcitol - injection, Zemplar. Available at: Pfi zer Announces FDA Approval Of Xeljanz XR (Tofacitinib Citrate) Extended-Release Tablets, The First And Only One-Daily Oral JAK Inhibitor Treatment For Rheumatoid Arthritis. Available at: zer.com/news/press-release/press-release-detail/pfi zer_announces_fda_approval_of_xeljanz_xr_tofacitinib_citrate_extended_ release_tablets_the_fi rst_and_only_once_daily_oral_jak_inhibitor_treatment_for_rheumatoid_arthritis. Preventing Chemotherapy-Induced Nausea and Vomiting. Available at: Promius Pharma Receives FDA Approval for Sernivo (betamethasone dipropionate) Spray, 0.05%. Available at: home/ /en/promius-pharma%e2%84%a2-receives-fda-approval-sernivo-betamethasone. TetraVisc. Available at: U.S. Food and Drug Administration Approves Gilead s Second TAF-Based Single Tablet Regimen Odefsey (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection. Available at: What Is Paricalcitol?. Available at: What is Xeljanz? Available at:

4 CDC Releases Opioid Guidelines The Centers for Disease Control and Prevention (CDC) released new clinical guidelines for managing chronic pain with opioids. An estimated 20% of patients presenting to physician offi ces with non-cancer related pain symptoms or pain-related diagnoses (including both acute and chronic pain) receive an opioid prescription. Approximately 3-4% of adults in the U.S. were prescribed long-term opioid therapy in 2015, and between1999 to 2014, more than 165,000 Americans died from overdoses related to opioid pain medications. Furthermore, while death rates for the leading causes of death, such as heart disease and cancer, have decreased substantially, the death rate associated with opioid pain medications has increased signifi cantly. The CDC s new opioid guidelines include recommendations for primary care clinicians who are prescribing these medications for chronic pain outside of active cancer treatment, palliative and end of life care. These guidelines are intended to assist healthcare providers in prescribing the most effective and safest therapy available for patients. The new guidelines include three general categories, within which there are a total of twelve recommendations. The recommendations are as follows: Determining when to initiate or continue opioids for chronic pain Non-pharmacologic therapy and non-opioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider opioid therapy only if the expected benefi ts for both pain and function are anticipated to outweigh the risks to the patient. If opioids are used, they should be combined with non-pharmacologic therapy and non-opioid pharmacologic therapy, as appropriate. Before starting opioid therapy for chronic pain, clinicians should establish treatment goals with their patients, including realistic goals for pain and function, and they should discuss how therapy will be discontinued if the benefi ts do not outweigh the risks. Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs the risks to patient safety. Before starting and periodically during opioid therapy, clinicians should discuss the known risks and realistic benefi ts of opioid therapy with patients and the responsibilities each party shares for managing therapy. Opioid selection, dosage, duration, follow-up, and discontinuation When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/ long-acting (ER/LA) opioids. When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, and should carefully reassess evidence of individual benefi ts and risks when increasing the dosage to 50 morphine milligram equivalents (MME)/day, and should avoid increasing the dosage to 90 MME/day or carefully justify a decision to titrate dosage to 90 MME/day. Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be suffi cient; more than seven days will rarely be needed. Clinicians should evaluate the benefi ts and harms of opioid therapy with patients within one to four weeks of starting treatment for chronic pain orbefore dose escalation. Clinicians should also evaluate the benefi ts and harms of continued opioid therapy with patients every three months or more frequently. If the benefi ts do not outweigh the harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids. (Continued on page 5)

5 CDC Releases Opioid Guidelines (Continued from page 4) Assessing risk and addressing harms of opioid use Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms. Clinicians should incorporate into the management plan strategies to mitigate risk, including the potential benefi ts of offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, higher opioid dosages ( 50 MME/day), or concurrent benzodiazepine use, are present. Clinicians should review the patient s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at high risk for overdose. Clinicians should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every three months. When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs. Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible. Clinicians should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder. These guidelines are intended to improve communication between clinicians and patients about the risks and benefi ts of opioid therapy for chronic pain, improve the safety and effectiveness of pain treatment, and reduce the risks associated with long-term opioid therapy, including opioid use disorder, overdose and death. The recommendations in the guideline are voluntary, rather than prescriptive standards and are based on observational studies and randomized clinical trials. WellDyneRx offers a full suite of clinical programs, including Pain Guardian, a fraud, waste, and abuse program developed to help identify high utilizers of chronic opioid therapy. CDC Guideline for Prescribing Opioids for Chronic Pain United States, Available at: Accessed April 5,