As a treatment for patients with acute pain,
nonsteroidal anti-inflammatory drugs (NSAID) have been used. However, the
prescription of NSAIDs has been associated with cardiovascular and
gastrointestinal risks.
Iroko Pharmaceuticals announced recently the FDA
approved the capsule ZORVOLEX. ZORVOLEX is a nonsteroidal
anti-inflammatory drug used to treat mild to moderate acute pain in adults.
ZORVOLEX is the first and only NSAID using SoluMatrix Fine Particle
Technology. Using this technology, ZORVOLEX contains diclofenac, which
reduces the particle sizes 20 times. This reduction in size, increases
the surface area, and contributes to faster dissolution. The effectiveness
was analyzed using a study of 428 patients, ages 18 to 65 whom had moderate to
severe pain. The patients were randomly divided into three groups with
three different forms of treatment. The groups included ZORVOLEX 35 mg 3
times a day, ZORVOLEX 18 mg 3 times a day, and placebo. The patients treated
with ZORVOLEX, 35 mg and 18 mg, reported significantly greater pain relief
compared with patients receiving the placebo.
The FDA has approved ZORVOLEX at the lowest
possible effective dosage. The FDA also recommends ZORVOLEX be used by
patients for the shortest amount of time. This is due to the
cardiovascular and gastrointestinal risks involved with a high dosage of
NSAIDs, which includes cardiovascular thrombotic events, myocardial infarction,
stroke, gastrointestinal ulcers, gastrointestinal bleeds, and acute renal
failure.
It is encouraging to know that a low-dose nonsteroidal anti-inflammatory
drug has been approved by the FDA and is available for physicians to prescribe
to patients with acute pain. However, it is important for acute pain
patients to carefully get prescribed a low dose of ZORVOLEX due to the risks
associated with a high dose of NSAIDs.
Source:
"Introducing
ZORVOLEX™ (diclofenac), the First Lower-Dose NSAID Developed Using SoluMatrix
Fine Particle Technology™." Pharmacy
Times, 12 Nov. 2013. Web. 08 Dec. 2013.
<http://www.pharmacytimes.com/publications/issue/2013/November2013/R613_November2013>.
I agree, I like the idea of having a low-dose non steroidal anti-inflammatories because it means that eventually if a patient needs to increase their dosage they can! For example, although it is a completely different medication when I first started my Sumatriptan for my migraines I started at like 10mg, now unfortunately i'm at 50mg in order to get any type of relief, but knowing that I was able to start at a lower dosage and receive relief is comforting to me because it means I am putting less into my body right of the bat. But also! Another thing I particular enjoyed was after doing more research this drug was just approved recently by the FDA - so I also like knowing that there are constantly drug adaptations being made by pharmaceutical companies to provide what works best for patients out there!
ReplyDeleteEven though ZORVOLEX has been FDA approved it sounds like a very risky NSAID to take. I would be very scared to be prescribed this knowing about the possible risk of stroke and GI ulcers and bleeds. However, the data on figure 1 does show a huge significance in pain intensity between ZOROVLEX and Placebo. This drug should definitely be prescribed safely and for a short period of time.
ReplyDeleteI have taken voltaren for my elbow which is a topical solution of diclofenac sodium and it worked wonders. I really liked the idea of having a topical solution of it because then it (hopefully) mostly only hits the affected area and should reduce the risk of thrombotic events and GI bleeding. However I imagine if you had a headache just rubbing voltaren gel on your head would probably not work.
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