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ZECUITY (formerly Zelrix Migraine Patch): Approved!

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ZECUITY, the drug formerly known as the Zelrix Migraine Patch, finally got its approval from the FDA on Thursday (the 17th of January 2013).  It should be available in the United States toward the end of this year.

Zecuity logo

The medication at the core of ZECUITY is familiar to most migraineurs – sumatriptan (which has been sold under the brand names such as Imitrex and Imigran).  But it’s much more than just another brand of the same thing.

Many migraineurs have found that common triptan drugs (such as this) don’t work for them.  There are a number of reasons for this, but a common one is that the medication is not getting to where it needs to be at the right time.  Drugs taken orally may sit in the stomach and not be delivered properly (due to gastric stasis, a common issue for migraineurs).  Or they simply don’t get it into their system fast enough to fight the migraine chain-reaction (remember, this is not a preventative – it’s taken for a specific migraine attack (abortive)).

Oh, and let’s not forget the nausea associated with migraine.  Who wants to take anything orally?!

This particular patch, which delivers the sumatriptan though your skin, contains a microprocessor.  The patch is “activated”, and delivers the medication using a mild electrical pulse.  This is known as iontophoretic delivery.

The microprocessor actually “customized” the delivery somewhat – monitoring how well it’s being absorbed and adjusting the delivery to match.

The advantages?  The medication is delivered at just the right time, in just the right amount.  Patients who were never helped by sumatriptan before may be helped now.  And patients who suffered from side effects before may now be able to avoid them.

This delivery patch is being used already for other medications, such as anti-inflammatories.  If it works well with sumatriptan (or should I say – if it sells well!), it will no doubt be used with other migraine medications.

Now for the question everyone is asking – does it hurt?

Generally speaking, the adhesive seems to be an issue for more people than the mild electric current.  If you have allergies to adhesives, the ZECUITY adhesive may cause problems.

The delivery of the medication may include a slight tingling or warm sensation – but from what I’ve heard so far it seems to be painless for most people.

Get more details at the official ZECUITY website.

Zelrix Migraine Patch NOT approved by FDA

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Migraine patients who are waiting for the launch of the new Zelrix Migraine patch, a patch that quickly delivers sumatriptan, will have to wait a while longer.

NuPathe Inc, developer of the patch, has been waiting on the FDA in the United States since October.  The plan was to launch the product during the first half of 2012, but now that seems to be overly optimistic.

The Zelrix Migraine Patch
The Zelrix Migraine Patch

The migraine medication patch isn’t just another drug delivery system.  It’s a single use patch that delivers the medication through the skin using an electrical current (iontophoresis).  This method is already used in drugs such as anti-inflammatories.

One of the goals of medication such as this is to get it into the system as quickly as possible.  Speed may make all the difference.  In addition, Zelrix may avoid some side effects due to the delivery method.

But the challenge with a patch like this is that it’s complex – not just a simple pill, but a piece of electronic technology (known by the company as SmartRelief).

The FDA expressed concerns about chemistry, manufacturing, and safety issues.  NuPathe quickly assured investors that it could quickly address these issues, likely starting on trials and studies soon.  The CEO of NuPathe, Jane Hollingsworth, said in a recent press release:

"This CRL [Complete Response Letter from the FDA] gives us confidence that we can provide the information needed to support FDA approval for our migraine patch in a timely manner.  We continue to believe that our patch will address the symptoms of millions of patients who suffer from debilitating migraine headache pain and migraine-related nausea.  We look forward to working with the FDA to bring this important product to market."

In spite of the assurance, NuPathe stocks took a major hit this morning.  Investors are looking at a very challenging market climate, with so many migraine drugs now available.

And yet, with so many migraine patients still dealing with major symptoms, there’s no doubt much more needs to be done.

Read the full press release from NuPathe here:  FDA Requests Additional Information Regarding NuPathe’s Migraine Patch in Complete Response Letter

More about the Zelrix Migraine Patch

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