Product Update

Zurampic (lesinurad) for High Uric Acid Associated With Gout

The FDA approved Zurampic (lesinurad) used in combination with a xanthine oxidase inhibitor (XOI) to treat hyperuricemia associated with gout. XOI is used to reduce the production of uric acid in the body.

Lesinurad helps the kidney excrete uric acid by inhibiting the function of transporter proteins involved in uric acid reabsorption in the kidney.

The safety and efficacy of the drug was evaluated in 3 randomized, placebo-controlled studies that tracked 1537 patients over 12 months. The study reported that lesinurad with XOI showed a reduced serum uric acid level when compared to placebo. The most common adverse reactions included headache, influenza, increased blood creatinine, and gastroesophageal reflux disease.

Lesinurad has a Boxed Warning including the risk for acute kidney failure, which is more common when used without an XOI or in higher than approved doses.

Zurampic is manufactured by AstraZeneca.

Uptravi (selexipag) for Pulmonary Arterial Hypertension

The FDA approved Uptravi (selexipag), an oral and selective IP prostacyclin receptor agonist. Selexipag, indicated for the treatment of pulmonary arterial hypertension (PAH), delays the disease progression and reduces the risk of hospitalization for PAH.

A long-term, placebo-controlled study of 1156 patients with symptomatic PAH (GRIPHON study) evaluated safety and efficacy. Patients had idiopathic and heritable PAH (58%), PAH associated with connective tissue disease (29%), and PAH associated with congenital heart disease with repaired shunts (10%). In this trial, exposure to selexipag was up to 4.2 years with median duration of exposure of 1.4 years.

Adverse reactions occurring more frequently compared to placebo were headache, diarrhea, jaw pain, nausea, myalgia, vomiting, pain in extremity, flushing, arthralgia, anemia, decreased appetite, and rash.

Uptravi is manufactured by Actelion.

Basaglar (insulin glargine injection) for Diabetes

The FDA approved Basaglar (insulin glargine injection), a long-acting human insulin analog to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

The injection is the first insulin product approved through an abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act.

Safety and efficacy was determined in 2 clinical trials enrolling 534 and 744 patients with type 1 and 2 diabetes mellitus, respectively. The most common adverse reactions found were hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site, itching, rash, edema, and weight gain.

The injection should be administered subcutaneously once daily at any time of day, but at the same time every day, and should not be used during episodes of hypoglycemia or in patients with hypersensitivity to insulin glargine or one of its ingredients.

Basaglar is manufactured by Eli Lilly and Company.

Bridion (sugammadex) Injection for Neuromuscular Blockade During Surgery

The FDA approved Bridion (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used during certain types of surgery in adults.

Rocuronium bromide and vecuronium bromide are neuromuscular blocking drugs that cause temporary paralysis by interfering with the transmission of nerve impulses to the muscle and are used to paralyze the vocal cords when patients require an artificial airway or breathing tube for surgery—a process called tracheal intubation. They can also be used to prevent patients from moving during surgery while they are receiving general anesthesia. Neuromuscular blocking drugs are also sometimes used to prevent the body from breathing automatically when a patient has to be placed on a ventilator.

The safety and efficacy of sugammadex were evaluated in 3 phase III clinical trials involving 456 participants, where recovery time was faster overall for the sugammadex treatment groups compared to the comparator groups. Sugammadex was further evaluated in a randomized, double-blind, parallel group, repeat-dose trial due to concerns about the nature and frequency of anaphylaxis and hypersensitivity reactions reported in the clinical trials. Of the 299 participants treated with sugammadex, 1 person had an anaphylactic reaction. Clinicians should be aware of the possibility of a hypersensitivity reaction or anaphylaxis and should intervene as appropriate.

Cases of marked bradycardia, some of which have resulted in cardiac arrest, have been observed within minutes after the administration of sugammadex. Patients should be closely monitored for hemodynamic changes during and after reversal of neuromuscular blockade, and treatment with anticholinergic agents, such as atropine, should be administered if clinically significant bradycardia is observed.

The most common adverse reactions reported in clinical trials included vomiting, low blood pressure (hypotension), pain, headache, and nausea. Doctors should also advise women using hormonal contraceptives that sugammadex may temporarily reduce the contraceptives effect so they must use an alternate method of birth control for a period of time.

Merck Sharp and Dohme Corp, a subsidiary of Merck and Company, Inc, markets Bridion.

Movantik (naloxegol) for Opioid-induced Constipation

The FDA approved Movantik (naloxegol) for opioid-induced constipation in adults with chronic non-cancer pain. Naloxegol is an oral treatment.

Designed to measure the change in the number of bowel movements per week from the start of the study, the safety and effectiveness of the drug were established in 2 clinical trials involving 1352 participants who had taken opioids for a minimum of 4 weeks for non-cancer related pain and had opioid-induced constipation. Participants were randomly assigned to receive 12.5 mg or 25 mg of naloxegol or placebo, once daily for 12 weeks.

The primary trial revaled that 44% of participants receiving 25 mg of naloxegol and 41 percent of participants receiving 12.5 mg of naloxegol experienced an increase in bowel movements per week, compared to 29% of participants receiving placebo. The second trial showed similar results. Common side effects of naloxegol include abdominal pain, diarrhea, headache, and the experience of excessive gas in the stomach or intestinal area (flatulence).

AstraZeneca Pharmaceuticals LP distributes Movantik.

Sumatriptan Injection USP For Migraines and Cluster Headaches

The FDA approved its Abbreviated New Drug Application (ANDA) for 4 mg/0.5 mL and 6 mg/0.5 mL sumatriptan injection USP in adults for the acute treatment of migraine and cluster headache when a clear diagnosis has been established. It is not intended for migraine prophylaxis or the treatment of cluster headaches.

Sumatriptan injection is contraindicated in patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes and in patients with other significant underlying cardiovascular diseases. Sumatriptan injection is contraindicated in patients with ischemic bowel disease. Sumatriptan injection and any ergotamine-containing medication, ergot-type medication, or another 5-HT1 agonist should not be used within 24 hours of each other. Sumatriptan injection is contraindicated in patients with hypersensitivity to sumatriptan and in patients with hepatic impairment.