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FDA-Approved: A Roundup of New Treatments on the Market

Healthcare professionals should be aware of the following newly approved drugs:

Cefaly: Migraine

A nerve-stimulating headband called Cefaly1 has won approval from the FDA for the prevention of migraine headaches.  It is the first transcutaneous electrical nerve stimulation system approved for pain prevention rather than acute treatment.

Cefaly delivers a steady current of electricity through the forehead and into the trigeminal nerve branches and is to be used for no more than 20 minutes a day.

In a trial of 67 adults randomized to either Cefaly or placebo, patients assigned to the device had 2 fewer headaches a month compared with baseline. 

The most common complaints while using the device were an uncomfortable feeling, sleepiness, and headache after treatment.
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AVEED: Low Testosterone

The FDA has approved the testosterone injection AVEED2 for the treatment of hypogonadism, or low T.

In a Phase 3 study, AVEED successfully increased and maintained testosterone levels in men (average age 54 years) for up to 10 weeks.

AVEED is administered via single 3 ml intramuscular injection. Injections are given at the initiation of therapy, at 4 weeks, and every 10 weeks after.

Bydureon Pen: Type 2 Diabetes

The Bydureon Pen3, a weekly injectable medicine for the treatment of adults with type 2 diabetes, has been approved by the FDA.

Bydureon is not a substitute for insulin, and should not be used concurrently with insulin. It is not recommended for the treatment of type 1 diabetes or diabetic ketoacidosis.

In a 24-week study, once-weekly Bydureon reduced HbA1c levels by 1.6 percentage points compared with 0.9 points with twice-daily BYETTA (exenatide) injection.

Indomethacin Capsules (Tivorbex): NSAID

The FDA has approved the new nonsteroidal anti-inflammatory drug (NSAID), Tivorbex,4 at both 20 mg and 40 mg doses. Tivorbex is used for the treatment of mild to moderate pain in adults.

The recommendation is supported by two Phase 3 placebo-controlled trials in which the NSAID demonstrated significant pain relief in patients with postsurgical pain.

In an attempt to lower the risks of adverse cardiovascular events associated with NSAID use, Tivorbex is distributed in capsules that are 20% lower in dosage than common 25 mg and 50 mg indomethacin products.

–Michael Potts

References

  1. FDA allows marketing of first medical device to prevent migraine headaches [press release] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm388765.htm
  2. U.S. FDA Approves AVEED(TM) (Testosterone Undecanoate) Injectable testosterone replacement therapy for men living with hypogonadism, or low-T [press release]. http://online.wsj.com/article/PR-CO-20140306-906700.html
  3. US FDA approves Bydureon Pen (exenatide extended-release for injectable suspension) for once-weekly treatment of adults with type 2 diabetes [press release]. http://www.astrazeneca.com/Media/Press-releases/Article/03032014-us-fda-approves-bydureon-pen
  4. New lower dose NSAID marks Iroko’s second FDA approval in approximately four months [press release]. http://www.businesswire.com/news/home/20140224006983/en/Iroko-Pharmaceuticals-Receives-FDA-Approval-TIVORBEX%E2%84%A2#.Ux9khF69NnI