Migraine Drug Zelrix Not Approved in FDA Vote

As I told you on Monday, the FDA voted on whether to approve NuPathe Pharmaceuticals' single-use sumatriptan migraine patch medication Zelrix on that same day. Unfortunately, the drug was not approved because the agency requires more information to make its decision. (You can learn more about the FDA approval process at this Migraine.com blog post I wrote: Zelrix Sumatriptan Patch & FDA Approval Process.)

In its complete response letter asking for more information from NuPathe, the FDA said the company has demonstrated the efficacy of the product. However, there are questions and concerns about other issues related to safety, chemistry and manufacturing.

In a press release NuPathe CEO Jane Hollingworth (FYI, she's a fellow migraineur) says the company believes it already has the information necessary to address the FDA's questions and concerns. Unfortunately NuPathe will no longer be able to launch Zelrix in the first half of 2012, as planned, but hopefully the product will be brought to market at some point because I think it holds great potential for migraine patients.

You can learn more about NuPathe's migraine-related nausea education efforts (and enter a contest to win an iPad 2!) at this link: Migraine-Related Nausea.

You can read more about Zelrix and the migraine-related issues it has been designed to address in these posts:

FDA to Vote on Zelrix Migraine Drug Approval
Why Are Pills Hard for Migraineurs to Use?
Migraine Medications 101: Triptans
Details of Sumatriptan Migraine Patch to be Released at IHS Meeting
Zelrix Transmits Sumatriptan Through Skin Patch


Sources:
FDA Requests More Study of Migraine Patch
FDA Requests Additional Information Regarding NuPathe's Migraine Patch in Complete Response Letter

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Content by Diana E. Lee.

DISCLAIMER: Nothing on this site constitutes medical or legal advice. I am a patient who is engaged and educated and enjoys sharing my experiences and news about migraines, pain and depression. Please consult your own health care providers for advice on your unique situation.

FDA to Vote on Zelrix Migraine Patch Approval

The Philadelphia Business Journal reports that the FDA will vote on approval of NuPathe Pharmaceuticals' electronic migraine patch called Zelrix on Monday, August 29. The Zelrix patch will provide a new delivery method for existing migraine treatment medication sumatriptan.

This spring I (and other migraine advocates) had the chance to work with NuPathe on a project to educate patients about migraine-related nausea (MigraineNausea.com). I can attest that they are an outstanding small company committed to helping provide migraine patients with options that truly meet their needs. Hopefully for both their sake and ours, the FDA will approve this fascinating new option for helping migraineurs treat their attacks without relying on their often problematic stomachs to process a medication.

To learn more about the Zelrix patch, visit these previous Somebody Heal Me posts about it and related issues:

Why Are Pills Hard for Migraineurs to Use?
Migraine Medications 101: Triptans
Details of Sumatriptan Migraine Patch to be Released at IHS Meeting
Zelrix Transmits Sumatriptan Through Skin Patch


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Content by Diana E. Lee.

DISCLAIMER: Nothing on this site constitutes medical or legal advice. I am a patient who is engaged and educated and enjoys sharing my experiences and news about migraines, pain and depression. Please consult your own health care providers for advice on your unique situation.

Latest Chronic Babe & PFAM Carnival Editions

Lest I allow myself to devolve into a complete carnival participant deadbeat, before the weekend officially arrives I want to share new editions of two awesome carnivals with you. I have posts in both, so it's especially important that I help spread the word. Enjoy!

Chronic Babe Carnival #34: What's Hot?

Patients for a Moment Carnival: Wordless Wednesday


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Content by Diana E. Lee.

DISCLAIMER: Nothing on this site constitutes medical or legal advice. I am a patient who is engaged and educated and enjoys sharing my experiences and news about migraines, pain and depression. Please consult your own health care providers for advice on your unique situation.

Migraine Safe Meal: Burritos with Homemade Taco Seasoning

When you start to read food package labels to avoid ingredients that tend to cause your migraine attacks, you notice how prevalent things like MSG are. Even when not called by that name. You can read more about food triggers, labeling and identifying other terms used for MSG on labels at this blog post I recently wrote for Migraine.com: Migraine Triggers: Food Triggers & Elimination Diets.

Ground beef tacos, enchiladas or burritos seem to appear on our dinner menu at least once a week. They're just so easy and tasty! In an effort to avoid the hidden MSG (and other unpronounceable ingredients) in most taco seasoning packets, I've started making my own mix. It's also much, much cheaper. Keep reading for the taco seasoning recipe and the recipe for my delicious, yet oh so Easy Peasy Beef & Bean Burritos.

Homemade Taco Seasoning
(download recipe in PDF)

For one pound ground beef (or chicken):

1/2 T cornstarch
1 T chili powder
1 tsp cumin
1 tsp oregano
1 tsp cocoa
1 tsp salt
1/2 tsp garlic powder
1/2 tsp onion powder
1/2 tsp black pepper
1/8 tsp cayenne pepper
1/8 tsp coriander
1/8 tsp paprika


Easy Peasy Beef & Bean Burritos
(download recipe in PDF)

    2 pounds ground beef
    1 medium onion, diced
    19 ounce can enchilada sauce
    homemade taco seasoning (doubled)
    16 ounce can refried beans
    3 c. shredded mild cheddar cheese or Mexican blend
    10-12 large flour tortillas (I like Mission Carb Balance)
    Optional toppings: sour cream, cilantro, Southwestern Ranch Veggie Dip
        (find premade on produce aisle or purchase packet on salad
        dressing aisle), shredded lettuce, diced tomatoes
  

Saute the onion until translucent. Add ground beef and brown. Add homemade taco seasonings and stir to combine. Pour in about half the enchilada sauce and simmer over low heat.

Heat the refried beans in a microwave-safe container. Add 1 c. shredded cheese and stir until melted.

Heat the tortillas in the microwave for about one minute.

Spread about 1/8 c. of beans on each tortilla. Add about 1/4 c. ground beef mixture. Sprinkle on some shredded cheese. Or a lot. Fold over ends and roll up. Put two burritos on a microwave-safe plate for each person. Pour some of the remaining enchilada sauce over the top and sprinkle generously with more cheese. Microwave each plate for one minute. Add optional toppings of your choice & serve immediately.



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Content by Diana E. Lee.

DISCLAIMER: Nothing on this site constitutes medical or legal advice. I am a patient who is engaged and educated and enjoys sharing my experiences and news about migraines, pain and depression. Please consult your own health care providers for advice on your unique situation.

Announcing September 2011 Headache & Migraine Blog Carnival

The theme of the September 2011 Headache & Migraine Disease Blog Carnival will be: "Building Resiliency: How do you bounce back when life kicks you in the chin? What can you share with fellow migraine & headache patients about how to build their coping skills to better handle unexpected, tough situations?" As always, posts on any topic related to migraine disease or other headache disorders are also welcome.

Entries are due by midnight (the end of the day) on Friday, September 9, 2011. The carnival will be published right here at Somebody Heal Me on Monday, September 12, 2011.

Feel free to post comments or contact me directly to ask any questions you might have. Please spread the word to any migraine or headache, pain or chronic illness bloggers you know and consider posting an announcement on your own blog if you have one.

For more information about the carnival please visit the main carnival page: Headache & Migraine Disease Blog Carnival. 

Thank you for your continued support of the Headache and Migraine Disease Blog Carnival!


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Content by Diana E. Lee.

DISCLAIMER: Nothing on this site constitutes medical or legal advice. I am a patient who is engaged and educated and enjoys sharing my experiences and news about migraines, pain and depression. Please consult your own health care providers for advice on your unique situation.

My New Do: Confidence From Foils

I got my hair colored yesterday and I'm sort of in love with the results. So much so I can't stop looking at myself in the mirror! Between the cut and the new color, I'm looking pretty great, if I do say so myself. My husband likes it a lot, too, which is always a good thing.

Just two weeks until our San Diego vacation!

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Content by Diana E. Lee.

DISCLAIMER: Nothing on this site constitutes medical or legal advice. I am a patient who is engaged and educated and enjoys sharing my experiences and news about migraines, pain and depression. Please consult your own health care providers for advice on your unique situation.

My Chronic Life in Pictures

In the call for submissions for the upcoming edition of the Patients for a Moment Carnival being hosted by my pal Rachel at Tales of Rachel, she asked us to capture our lives as patients in pictures rather than words. Here's what I came up with.



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Content by Diana E. Lee.

DISCLAIMER: Nothing on this site constitutes medical or legal advice. I am a patient who is engaged and educated and enjoys sharing my experiences and news about migraines, pain and depression. Please consult your own health care providers for advice on your unique situation.

Brynn's Birthday Weekend

I had the pleasure of spending the weekend with my great friend Dulcinea and her family to celebrate her beautiful little girl Brynn's first birthday and baptism. We took a trip to the zoo during the day on Saturday, celebrated with a wonderful party on Saturday night and welcomed her into God's family with a lovely baptismal service and lunch on Sunday. It's wonderful to be part of the lives of such special friends and their amazing children.





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Content by Diana E. Lee.

DISCLAIMER: Nothing on this site constitutes medical or legal advice. I am a patient who is engaged and educated and enjoys sharing my experiences and news about migraines, pain and depression. Please consult your own health care providers for advice on your unique situation.

Migraine Chat Reminder: Tonight!

Don't forget to join us for Migraine Chat tonight from 6-7 pm CT. We'll be talking about how you cope when life pulls the rug out from under you, as it so often seems to when you're living with a chronic illness like migraine disease. Hope to see you there tonight!

For more information visit: Migraine Chat.

Post a comment here, email me or hit me up at Facebook or Twitter if you have questions.

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Content by Diana E. Lee.

DISCLAIMER: Nothing on this site constitutes medical or legal advice. I am a patient who is engaged and educated and enjoys sharing my experiences and news about migraines, pain and depression. Please consult your own health care providers for advice on your unique situation.

Summer's Not Over! Our Upcoming Vacation

Although for most of you summer is likely over, especially if you have kids returning to school, for us it's not quite gone. We've planned a week long trip to San Diego at the beginning of September. It can't come soon enough!



I can't wait to spend an entire week away with my husband. This is our first vacation together in five years, so we really need it!

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Content by Diana E. Lee.

DISCLAIMER: Nothing on this site constitutes medical or legal advice. I am a patient who is engaged and educated and enjoys sharing my experiences and news about migraines, pain and depression. Please consult your own health care providers for advice on your unique situation.

Found: Free Medication Reminder App for iPod, iPad

If you have an iPhone, iPod Touch or iPad and need reminders to take your medications throughout the day, the Pillboxie app is perfect for you.

It's not only extremely useful, it's also a cute approach to a mundane task. To set reminders you drag pills and drop them into your virtual pillbox. You'll get your reminder alarms even if your device is asleep or not connected to the Internet.

Download the Pillboxie application in the AppStore: Pillboxie.

Do you use an application on your phone to schedule medication reminders? Which one? What do you like about it?

The Found Series is a collection of posts highlighting useful, easily accessible tools of great use to just about anyone living with migraines.

Related Posts:
Found: Be Kind to Your Brain
Found: CFL Covers
Found: Blackle
Found: Hot/Cold Pads & Aromatherapy Spray on Etsy
Found: Handheld Digital Thermometer for Biofeedback Training
Found: 'Memo to Me' Free Email Reminders
Found: 'Head Case' Essential Oil Blend for Migraineurs
Found: Colgate Wisp Disposable Toothbrush

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Content by Diana E. Lee.

DISCLAIMER: Nothing on this site constitutes medical or legal advice. I am a patient who is engaged and educated and enjoys sharing my experiences and news about migraines, pain and depression. Please consult your own health care providers for advice on your unique situation.

Happy Places: Patients for a Moment Carnival

The latest edition of the Patients for a Moment Carnival was posted yesterday at Fibrodaze. The theme for this collection is Your Happy Place. I submitted a place about books, which are undoubtedly my happy place. Check out all the other great posts.

Patients for a Moment Carnival: All the Happy Places

The next edition of Patients for a Moment is on August 24, 2011, and will be hosted by my awesome pal Rachel at http://talesofrachel.com/.


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Content by Diana E. Lee.

DISCLAIMER: Nothing on this site constitutes medical or legal advice. I am a patient who is engaged and educated and enjoys sharing my experiences and news about migraines, pain and depression. Please consult your own health care providers for advice on your unique situation.

Bouncing Back When Life Knocks You Down

Everyone gets thrown for a loop by life from time to time, but when you're living with the ramifications of a debilitating chronic illness, this seems to happen all the time. Whatever expectations you had for yourself and your life seem like a sick joke, and it becomes clear that whatever control you thought you had doesn't exist. So how do you bounce back when life kicks your butt?

Here are 5 tips for preparing yourself to respond with resilience next time life comes out of left field and ruins your plans:

1. Develop stress-management skills. Practice these at all times so your coping muscles are well-trained when you need to rely on them. Guided relaxation and mindfulness meditation are great tools for this. Check out my posts tagged with meditation and behavioral pain management for more ideas about developing these skills.

2. Practice self-care. Self-care involves all the day-to-day practices of healthy living. Exercising, eating right, getting the correct amount of sleep (not too little or too much), not drinking too much or using recreational drugs and practicing relaxation techniques are all part of self-care.  (For more about self-care, check out this Psychology Today article: Self-care in a toxic world.)

3. Develop a strong support system. Who can you count on when the stakes are high? Know who these people are so you can call upon them when things get rough. For me this includes my husband, immediate family, close real life friends and message board friends (including fellow chronic buddies).

4. Practice staying in the moment. A set back right now says nothing about your entire life or what will happen as soon as tomorrow. As Toni Bernhard says in her weather practice (in her book How to Be Sick), "The weather blew the discomfort in and may blow it out at any moment."

5.  Just breathe. Sometimes when you're upset, regular, healthy breathing is one of the first things to go. I know it is for me. When I slow down and focus on taking controlled, relaxing breaths it almost always helps me do all the other things that help me cope when life throws me a curve ball.

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Content by Diana E. Lee.

DISCLAIMER: Nothing on this site constitutes medical or legal advice. I am a patient who is engaged and educated and enjoys sharing my experiences and news about migraines, pain and depression. Please consult your own health care providers for advice on your unique situation.

August 2011 Headache & Migraine Blog Carnival Posted

Thanks to Nancy Harris Bonk of the blog Migraine & Other Headache Disorders for her hard work in putting together this month's carnival! Be sure to visit the link and read all the fantastic submissions.

August 2011 Headache & Migraine Blog Carnival: Favorite Post of the Month


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Content by Diana E. Lee.

DISCLAIMER: Nothing on this site constitutes medical or legal advice. I am a patient who is engaged and educated and enjoys sharing my experiences and news about migraines, pain and depression. Please consult your own health care providers for advice on your unique situation.

On Migraine.com: Migraine Med Levadex Accepted for FDA Review

My latest post at Migraine.com is about the FDA approval process and a drug in development called Levadex. This article provides a good overview of the process in laymen's terms.

MAP Pharma’s New Drug Application for Levadex Accepted for Review




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Content by Diana E. Lee.

DISCLAIMER: Nothing on this site constitutes medical or legal advice. I am a patient who is engaged and educated and enjoys sharing my experiences and news about migraines, pain and depression. Please consult your own health care providers for advice on your unique situation.

Last Call: August 2011 Headache & Migraine Blog Carnival

Please don't forget today is the deadline for submissions to the August 2011 Headache & Migraine Disease Blog Carnival. Our theme for August is "Your favorite post since the last carnival"

Submit your blog article by emailing your submissions directly to me (somebodyhealme AT dianalee DOT net).

Entries are due by midnight (the end of the day) today, Friday, August 5, and the carnival will be posted by Nancy Harris Bonk at Migraines & Other Headache Disorders on Monday, August 8.

Please let me know if you are interested in hosting a future edition. Contact me any time with questions, suggestions or ideas for themes. I'm always looking for help with the carnival. Don't hesitate to post a comment or email me with questions.


Subscribe to the Somebody Heal Me feed: Subscribe in a reader or subscribe by e-mail. Follow me on Twitter @somebodyhealme. 

Content by Diana E. Lee.

DISCLAIMER: Nothing on this site constitutes medical or legal advice. I am a patient who is engaged and educated and enjoys sharing my experiences and news about migraines, pain and depression. Please consult your own health care providers for advice on your unique situation.

My Happy Place: Lost in a Book

Finding a happy place amidst all the chaos of living with a chronic illness is essential to successfully coping. For me getting lost in a good book has always been a very happy place, but since I've been sick it's taken on new importance.

Lately I've been really into mysteries. It's so easy to get lost in a great mystery, which allows you to get go of anything troubling you and can help distract you from excruciating pain for at least a little while. I started reading Agatha Christie's mysteries earlier this year, and I can't get enough of them! She wrote the best characters and was a master at adding a jaw-dropping twist. The Murder of Roger Ackroyd is a great example of her gift for twist endings.

You also can't beat Sherlock Holmes stories for a great way to pass some time and distract yourself. A great place to start with Sir Arthur Conan Doyle's series is The Hound of the Baskervilles. It's well known for good reason.

By now almost everyone who is interested in doing so has read Stieg Larsson's Millenium Trilogy but on the off chance one of you hasn't, you must get these books and give them a shot. They've gripping, intricately woven and highly entertaining. The three-book series includes The Girl with the Dragon Tattoo, The Girl Who Played with Fire and The Girl Who Kicked the Hornet's Nest.

Another good series is Alan Bradley's Flavia de Luce series. It's a bit more lighthearted and lots of fun. You'll quickly fall in love with Bradley's main character, a precocious girl whose curiosity comes in handy when weird things happen in her little English village. The Sweetness at the Bottom of the Pie is the first book in this series.

What is your happy place? If it's in books like it is for me, what are some of your favorites?

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Content by Diana E. Lee.

DISCLAIMER: Nothing on this site constitutes medical or legal advice. I am a patient who is engaged and educated and enjoys sharing my experiences and news about migraines, pain and depression. Please consult your own health care providers for advice on your unique situation.

On Migraine.com: Migraine Medication Telcagepant is Officially Dead

I've written an article for Migraine.com about the demise of Merck's investigational migraine treatment medication telcagepant and the status of other CGRP receptor antagonists, which many people think are the future of of migraine treatment.

Migraine Medication Telcagepant is Officially Dead

Sources:
Merck kills PhIII Drug Program
Calcium Gene-Related Peptide Receptor Antagonists in the Treatment of Migraine
Olcegepant: Novel Therapy for Acute Migraine

Related Posts:
Migraine Drug Telcagepant to Undergo Another Clinical Safety Study
News: Telcagepant to be Abandoned by Merck?
Telcagepant & The Future of Migraine Prevention
Possible Genetic Explanation for Migraine
Migraine News Roundup 34

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Content by Diana E. Lee.

DISCLAIMER: Nothing on this site constitutes medical or legal advice. I am a patient who is engaged and educated and enjoys sharing my experiences and news about migraines, pain and depression. Please consult your own health care providers for advice on your unique situation.

Chronic Sex: Does it Exist?

Trying to have a sex life as a person with chronic illness is hard. (No pun intended, seriously.) The longer you go without intimate contact, the greater the distance grows between you. It becomes awkward. And getting back in the saddle is harder for women than it is for men, I think.

I certainly don't have all the answers (I sure wish I did), but a recent Chronic Babe Carnival focused on this issue and the submissions are great reading if you're facing this issue, too: Blog Carnival #30: Let's Talk About Sex.

Additionally, a great resource is this book, The Ultimate Guide to Sex & Disability by Miriam Kaufman, Cory Silverberg and Fran Odette.

How does this issue affect you? How do you cope with it? is you partner understanding?