New FDA Approvals
New medications have recently been approved by the FDA for cardiovascular patients, diabetes, muscular dystrophy, and seizures — to name a few.
Yospral from Aralez Pharmaceuticals is a combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI), for patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers.
Zinplava from Merck is indicated to reduce recurrent Clostridium Difficile Infection (CDI) in patients receiving antibacterial treatment for CDI. Zinplava is not an antibiotic and is not indicated for treatment of CDI. It should only be used in conjunction with antibacterial drug treatment of CDI.
Adlyxin from Sanofi Aventis will help adults with type II diabetes by increasing glucose-dependent insulin release, and decreasing glucagon secretion. It will also slow gastric emptying. Adlyxin is to be used in conjunction with a healthy diet and exercise.
For patients with AIDS who also suffer from anorexia, Syndos from Insys Therapeutics is now available. Syndos is also approved for nausea and vomiting associated with chemotherapy in cancer patients who have failed to respond well to other anti-nausea treatments.
Another new drug was approved for the prevention of chemotherapy-induced nausea and vomiting. Sustol from Heron Therapeutics is an extended release injection specifically indicated for use in combination with other anti-nausea treatments in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.
Patients with a Duchenne muscular dystrophy with mutated DMD gene amenable to exon 51 skipping may have a new option in Exondys 51 from Sarepta. This new medication was granted accelerated approval based on an observed increase in dystrophin in skeletal muscle in some patients. A clinical trial of this new medication has not been established and continued approval may be contingent of a confirmed clinical benefit in a trial.
Carnexiv from Lundbeck is a replacement therapy for oral carbamazepine when oral administration is not feasible, in adults with seizures. Carnevix is supplied as an injection for intravenous administration.
Troxyca ER from Pfizer is new on the market for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment. Troyxca ER is an extended release capsule formulation of oxycodone combined with naltrexone. Oxycodone is a full opioid agonist and naltrexone is an opioid antagonist.
Two new drugs are now available for the treatment of certain cancers.
Keytruda from Merck has been approved for the treatment of head and neck squamous cell cancer. Keytruda is a programmed death receptor-1 (PD-1)-blocking antibody specifically indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.
Lartruvo from Eli Lilly has been approved for the treatment of soft tissue sarcoma. Lartruvo is specifically indicated for use in combination with doxorubicin, for the treatment of adult patients with soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery.
Talk to your doctor about your specific condition and if any of these medications are right for you. Like most medications, all come with a list of potential side-effects.
Sources: FDA and Centerwatch