Showcase, September 2015

New approvals, indications, generic, app; first 3D printed drug

New approval

FDA approved dichlorphenamide (Keveyis—Taro Pharmaceutical Industries) 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.

Dichlorphenamide is the first drug approved by FDA for the treatment of the disorder, which is estimated to affect approximately 5,000 people in the United States.

In clinical studies, the drug’s most common adverse effects were a burning or pricking sensation, difficulty thinking and paying attention, changes in taste, and confusion. 

The manufacturer has created the Keys2Care program, which will provide patient support services to ensure people diagnosed with periodic paralysis can receive treatment as soon as possible. As part of this program, the company is working with Diplomat, a specialty pharmacy, to offer access and support to patients who are prescribed dichlorphenamide and their caregivers.

The manufacturer expects the medication to become available during the third quarter of 2015. To be notified when the medication becomes available, enroll at

New indications

FDA approved eltrombopag (Promacta—Novartis) to treat pediatric patients aged 1 year and older who have thrombocytopenic purpura (ITP), a rare blood disorder that results in an abnormally low number of platelets. Without enough platelets, bleeding can occur under the skin, in mucous membranes (such as in the mouth), or in other parts of the body. Eltrombopag helps increase blood platelet production.

The drug is available as a tablet taken once daily or as a powder that is mixed with liquid for children aged 1–5 years to take orally. It was first approved in 2008 to treat adult patients with the same condition.

The agent should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding and in children who have not achieved an appropriate response using other ITP medications or surgery to remove the spleen.

In clinical trials, the most common adverse effects in children aged 1 year and older were infections of the upper respiratory tract or nose and throat, diarrhea, abdominal pain, rash, and increase in liver enzymes.

FDA granted eltrombopag orphan drug designation because it treats a rare disease.

FDA approved extended-release oxycodone (OxyContin—Purdue Pharma) for long-term pain management in children aged 11–16 years whose pain has not responded to alternative treatments. 

Approval was based on manufacturer-conducted studies on the safety of extended-release oxycodone and its pharmacokinetic profile in pediatric patients. The painkiller can only be prescribed to children who already tolerate at least 20 mg/d of oxycodone or its equivalent.

The product was reformulated in 2010 to make it more difficult to abuse.

New generic

Aurobindo Pharma Ltd. received FDA approval for 
cetirizine hydrochloride 
tablets in 5-mg and 10-mg strengths. The OTC medication is a generic of Zyrtec 5-mg and 10-mg tablets. 

It temporarily relieves symptoms of runny nose, sneezing, itchy, watery eyes, and itching of the nose or throat resulting from hay fever or other upper respiratory allergies.

FDA approves first treatment for sexual desire disorder

Flibanserin (Addyi—Sprout Pharmaceuticals) has been FDA approved to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Before flibanserin’s approval, no FDA-approved treatments were available for sexual desire disorders in men or women.

Flibanserin was approved with a Risk Evaluation and Mitigation Strategy (REMS), which includes elements to ensure safe use, because of the increased risk of severely low blood pressure and loss of consciousness resulting from the interaction between flibanserin and alcohol. Because of the alcohol interaction, use of alcohol is contraindicated while taking flibanserin. Health professionals must assess the likelihood of the patient reliably abstaining from alcohol before prescribing the medication.

The REMS requires that prescribers be certified with the REMS program by enrolling and completing training. Certified prescribers must counsel patients using a patient–provider agreement form about the increased risk of severe hypotension and syncope and about the importance of not drinking alcohol during treatment. In addition, pharmacies must be certified with the REMS program by enrolling and completing training. Certified pharmacies may dispense flibanserin only to patients with a prescription from a certified prescriber. Pharmacists must also counsel patients prior to dispensing not to drink alcohol during treatment.

Flibanserin is being approved with a boxed warning to highlight the risks of severe hypotension and syncope in patients who drink alcohol during treatment with flibanserin, in those who also use moderate or strong CYP3A4 inhibitors, and in those who have liver impairment. Flibanserin is contraindicated in these patients.

FDA is requiring the manufacturer to conduct three well-designed studies in women to better understand the known serious risks of the interaction between flibanserin and alcohol.

Flibanserin is taken once daily at bedtime to help decrease the risk of adverse events occurring as a result of possible hypotension, syncope, and central nervous system depression (such as sleepiness and sedation). Patients should discontinue treatment after 8 weeks if they do not report an improvement in sexual desire and associated distress.

Flibanserin 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.

First 3D printed drug gets FDA okay

FDA has approved levetiracetam (Spritam—Aprecia Pharmaceuticals) 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. 

Aprecia’s ZipDose Technology platform 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 FDA approved.

ZipDose Technology enables the delivery of a high drug load, up to 1,000 mg in a single dose. In addition, no measuring is required, as each dose is individually packaged, making it easy to carry this treatment on the go.

The product is expected to be available in the first quarter of 2016.

Hot new app: Save on prescription drugs

The newly launched app OneRx, a prescription drug savings tool, enables users to review drug pricing and benefits data. Users can compare the costs of carrier-specific drug copays with additional, comprehensive money-saving options that are available regardless of insurance status. 

The app takes into account hundreds of manufacturer coupons, pharmacy discounts, and other deals available to those with and without health insurance. It also makes available a prescription benefit option specifically for those without coverage, offering deals nationwide from pharmaceutical manufacturers and pharmacies that average $750 in savings per user annually.

The app automates the process of amassing coupons and saves time by providing users with automatic alerts when drug-specific insurer restrictions surface, ensuring that patients have the opportunity to troubleshoot these issues in the health care provider’s office and before making the trip to the pharmacy—a unique feature that increases adherence and overall health. 

OneRx is free, HIPAA compliant, and independently owned. It is currently available for download on iTunes and in the Google Play store.