The Legal Examiner Mark The Legal Examiner Mark The Legal Examiner Mark search twitter facebook feed linkedin instagram google-plus avvo phone envelope checkmark mail-reply spinner error close
Skip to main content

Axsome Therapeutics, Inc., a biopharmaceutical company dedicated to developing therapies for the treatment of pain and other central nervous system disorders, announced last month that the first patient has been enrolled in the CREATE-1 (CRPS Treatment Evaluation 1) study, a Phase 3 trial evaluating the effectiveness and safety of disodium zoledronate (AXS-02) in the treatment of the pain associated with complex regional pain syndrome (CRPS), also known as reflex sympathetic dystrophy (RSD).

The CREATE-1 study is expected to enroll 190 patients at sites in the U.S., Canada, Europe, and Australia. Eligible patients will be treated with either AXS-02 or a placebo, and the primary objective will be to measure the change in patient-reported pain intensity, measured with the Numerical Rating Scale.

FDA Fast Tracks AXS-02

In March 2015, the U.S. Food and Drug Administration (FDA) granted “Fast Track” designation to AXS-02 for the treatment of the pain associated with CRPS/RSD. AXS-02 is an osteoclast inhibitor being developed as an oral, non-opiod medication to treat the chronic pain. It is an investigational medication not yet approved by the FDA, and its safety and efficacy have not yet been determined.

Fast Track designation typically expedites approval by providing greater access to and more frequent communication with the FDA throughout the drug development and review process. Fast Track designation also gives Axsome Therapeutics the opportunity to potentially submit sections of the AXS-02 new drug application on a rolling basis, allowing the medication to be considered for priority review at the time of submission.

About CRPS/RSD

CRPS/RSD is a debilitating condition characterized by severe and chronic pain in a limb, accompanied by autonomic, sensory, motor, and trophic changes. The pain and associated loss of function results in significant and sometimes permanent disability for many patients, and there is no non-opiod drug currently approved to treat CRPS/RSD in the U.S. or the European Union.

 

25 Comments

  1. Gravatar for Stormy Mclaughlin
    Stormy Mclaughlin

    My 15 year-old son has suffered from complete body RSD for almost 5 years. We are currently doing Lyrica. As a mother I am desperate to help my son unfortunately I am having issues getting him on his father's insurance we are divorced and As of now my son only has Mississippi Medicaid which doesn't cover outta state treatment so any good treatment he gets comes outta pocket which is hard on my family. I would be amazingly grateful to see if this could help my son.

  2. Gravatar for Lacey

    I am very interested in this study. I live near Philadelphia Pennsylvania. I developed CRPS as a result of a traumatic car crash on 6/26/14. Please send me any information on how to be involved! Thank you!

  3. Gravatar for Clare Poncin

    My CRPS was caught early, broken fibula, only using Gabapentin 3 times a day. Would love to be part of this study.

  4. Gravatar for Twyanna

    I was diagnosed in 1998 been thru a lot. SCS(2) and medicine pump all removed. taking so many medications to get relief i would love to be a part of this study.

  5. Gravatar for Mendie

    I was rx'd with RSD 10 years ago. Due to a work injury I'm with workers compensation, so they don't approve much, I'm just a number. I'm on a multitude of medication.

    I'm Very interested in this study. Living in Mississippi. Can't wait to hear from you.

  6. Gravatar for Jennifer

    I am taking part in this study! I am beyond excited to help researchers determine if this can help those of us suffering from CRPS! Thanks for this article and for keeping CRPS in the spotlight!!!

  7. Gravatar for Stephen S. Rodrigues, MD
    Stephen S. Rodrigues, MD

    RSD is one of the many complex pain syndromes that is embedded in the muscle system aka myofascial pain and dysfunction. Other pain syndromes in this category of pain are: Trigeminal Neuralgia, Pudendal Neuralgia, Restless Leg syndrome, IBS, TOS, Whiplash and CTS. Also incomplete and thus masqueradeing named tension headaches, Migraines, Degenerative Joint Disease arthritis, rheumatism and diabetic nerve pain. Even chronic fatigue and fibromyalgia.

    Denied by the majority in the Allopathic world of medicine and misunderstood by many even in the CAM world. This category of pain is documented in the historical archives of medicine that the treatment are all valid, vetted, safe, highly effective and restorative. ⇒ without pills or surgery.

    Clues are: If you have ongoing, invisible pain and misery; think the muscle system.

    Any stubborn array of aches, weird pains, stiffnesses, tension in the face, jaw, scalp, neck, shoulders or pelvic floor; with all blood test and MRIs normal. Even Fatigue, frustration and insomnia.

    Truth: The skeleton and nerves can not be the primarily cause of pain without a smoking gun; space occupying lesion like a tumor or growth. Those who might blame the bone or a nerve have missed a few points related to how nature, biology and the human body works.

    Pain in the muscle system can only be removed by our own natural healing forces from within. There are only 3 ways to assist in the stimulation of our own natural healing forces into action deep within the muscle bundles. All of them have something in common and that is the application of a “force” which will ignite natural healing. 1) Out-side the muscles with hands and tools. 2) Inside the muscles with thin stimulative needling. 3) Inside the muscles with hypodermic stimulative needling. Add in wellness, sleep, magnesium, heat, stretching, range of motion exercises, aerobics and you have the full spectrum of all of the safe, natural and restorative holistic healing remedies blended into your plan of action.

  8. Gravatar for pat

    Obviously Dr Rodrigues does not have, or deal with CRPS pts. Comments like needling the muscles, using force as in using hands and tools on the muscles show that you do not understand the disease I am an RN diagnosed with CRPS 3 yrs ago . Started in my right foot after a TMA, and has now spread to above my knees in both legs, and I suspect into my lower back as well. There aren't many pts. that can even handle anyone "touching" their affect limbs, let alone massaging!. As far as safe and effective? Needling is neither. There are numerous research articles stating that something as small as a blood draw can cause CRPS to spread, so no, I don't think needling is safe or effective for most patients. There are plenty of holistic aids that help the patient tolerate the pain, but it very rarely goes into remission. It is a lifelong misery. If a pharm company can come up with a safe medication that at least diminishes the pain, then there is nothing wrong with patients who want to try and see if it will help them. Have some compassion DR.! You have missed a few points in your charactization of CRPS pts. We are not ignorant,uninformed, or just wanting drugs. The pain is REAL. The only sentence that I agree with is your last one. Yes we try a combo of anything that works for us. Some search for years to find relief, others never find it. I hope you treat your patients more compassionately than you seem to be stating in your response. You come off as a not so caring person, advocating "force" for treatment.

  9. Gravatar for Deb Murray

    I'm very interested in learning more about this new program. My 17 year old daughter was diagnosed at age 13 with RSD following a sports injury to her foot. She was diagnosed within 3 week of her injury, has had extensive PT, but she has had spread to her other foot, both knees, and both hands. We fight to keep her pain free, especially on bad weather days and struggle with vibration. In just two years she will be in college and our focus is to do everything we can to assure she will be able to achieve her childhood dream of becoming a veterinarian. Thank you to everyone involved in the continued research to find better treatments for CRPS.

Comments are closed.

Of Interest