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10 New Drug Approvals for Techs to Know
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Learn about the new drugs and expanded indications approved by the FDA in October 2015.
Learn about the new drugs and expanded indications approved by the FDA in October 2015.
The FDA approved Alkermes’ extended-release aripiprazole lauroxil injection (Aristada) on October 5, 2015.
Aristada, which is indicated for the treatment of schizophrenia in adults, is the first atypical antipsychotic with once-monthly and 6-week dosing options. This allows the drug to maintain its therapeutic benefits for an extended period of time and enables health care providers to better track patient adherence.
Like other atypical antipsychotics, Aristada is not indicated for the treatment of dementia-related psychosis, and includes a boxed warning alerting health care professionals about the increased risk of death associated with this off-label use.
The most common adverse events reported by trial participants treated with Aristada include akathisia, insomnia, and headache.
On October 26, 2015, the FDA approved Endo Pharmaceuticals and BioDelivery Sciences’ buprenorphine buccal film (Belbuca) for the management of chronic pain severe enough to require daily, around-the-clock opioid treatment and for which alternative therapies are inadequate.
The first and only dissolving buprenorphine film to receive the FDA’s nod, Belbuca was developed using BioDelivery Sciences’ BioErodible MucoAdhesive technology, which allows the drug to be delivered across the inside lining of the cheek.
The most common adverse reactions reported by trial participants treated with the drug include nausea, constipation, headache, vomiting, fatigue, dizziness, somnolence, diarrhea, dry mouth, and upper respiratory tract infection.
The manufacturers plan to launch Belbuca in 7 dosage strengths during the first quarter of 2016.
The FDA approved Tris Pharma’s extended-release amphetamine oral suspension (Dyanavel XR) on October 20, 2015.
Dyanavel XR is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children ages 6 years and older. With the FDA’s nod, the drug is now the first and only once-daily, extended-release, amphetamine-based oral liquid to be approved for this purpose.
The most common adverse events reported by trial participants treated with Dyanayel XR include epistaxis, allergic rhinitis, and upper abdominal pain.
On October 1, 2015, the FDA approved Allergan’s Juviderm Ultra XC for lip augmentation in adults ages 21 or older.
Indicated for injection into the lips and perioral area, the gel is now the only dermal filler approved to last up to 1 year in the lips.
The most common side effects associated with the use of Juviderm XC injectable gels occur at the injection site and include redness, swelling, tenderness, pain, discoloration, and itching. Additionally, patients taking medications that can prolong bleeding such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), and warfarin may experience increased bruising or bleeding at injection sites.
Those who have received Juviderm Ultra XC typically experience these side effects for up to 14 days.
The FDA approved a new treatment combination of Gilead’s ambrisentan (Letairis) with tadalafil on October 2, 2015.
This combination is indicated for the treatment of pulmonary arterial hypertension and also designed to reduce the risk of hospitalization for worsening symptoms and improve exercise ability.
Adverse events associated with the use of ambrisentan in combination with tadalafil include headache, nasal congestion, cough, and anemia. The combination treatment is not recommended for women who are breastfeeding or those who may be pregnant.
On October 16, 2015, the FDA granted accelerated approval to Boehringer Ingelheim’s intravenous solution idarucizumab (Praxbind) for the rapid reversal of the manufacturer’s anticoagulant, dabigatran (Pradaxa).
Praxbind is the first reversal agent approved specifically for Pradaxa, which initially received the FDA’s nod in 2010 for the prevention of stroke and systemic blood clots in patients with atrial fibrillation, as well as for the treatment and prevention of deep venous thrombosis and pulmonary embolism.
The most common adverse events associated with the drug’s use include headache, hypokalemia, confusion, constipation, fever, and pneumonia. The drug’s labeling recommends that patients resume their anticoagulant therapy as soon as medically appropriate, as reversing the effect of Pradaxa exposes patients to the risk of blood clots and stroke from their initial condition.
Seebri Neohaler and Utibron Neohaler
The FDA approved 2 Novartis inhalation powders on October 29, 2015.
The manufacturer’s indacaterol/glycopyrrolate inhalation powder (Utibron Neohaler) is indicated for the long-term maintenance treatment of COPD, while its glycopyrrolate inhalation powder (Seebri Neohaler) is approved for use as a stand-alone COPD monotherapy.
Both drugs are delivered via Novartis’ low-resistance Neohaler inhaler, allowing them to be more easily administered by patients with different severities of airflow limitation.
The most common adverse events reported by trial participants treated with Utlibron Neohaler include sore throat, runny nose, high blood pressure, and back pain. The drug is not indicated for asthma and should not be initiated in acutely deteriorating COPD patients or for the relief of acute symptoms.
Novartis plans to launch both Utibron and Seebri in the first quarter of 2016.
On October 21, 2015, the FDA approved Relypsa’s oral suspension patiromer (Veltassa) for the treatment of hyperkalemia, a condition in which a patient’s blood contain an elevated level of potassium.
Veltassa reduces the absorption of potassium by binding to it in a patient’s gastrointestinal tract.
The most common adverse reactions reported by trial participants treated with the drug include constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort, and flatulence.
Veltassa was also approved with a boxed warning cautioning patients and providers that the drug may decrease the absorption and reducing the effects of other drugs, and recommending that patients take it and any other orally administered medication at least 6 hours apart.
The FDA approved Iroko Pharmaceuticals’ 5 and 10 mg meloxicam (Vivlodex) capsules on October 23, 2015.
This NSAID was approved for the once-daily management of osteoarthritis pain.
It is the first FDA-approved low-dose meloxicam developed using the manufacturer’s SoluMatrix Fine Particle Technology, in which the meloxicam particles are approximately 10 times smaller than their original size. This reduction provides the drug with an increased surface area, allowing it to be more quickly dissolved and absorbed.
