After more than 20 years of waiting, a new drug for the treatment of sickle cell was finally approved by the FDA on Friday (July 7, 2017), bringing the total to two (the other being Hydroxyurea). Developed by Emmaus Medical, the new drug Endari uses the amino acid L-glutamine to help reduce the occurrence of cell sickling in warriors ages 5 and older. The FDA reports that side effects for Endari include constipation, nausea, headache, abdominal pain, chest pain, back pain, coughing, and pain in the extremeties.
In a recent interview with NBC BLK, Dr. Alexis A. Thompson, head of Hematology at the Ann and Robert H. Lurrie Children's Hospital of Chicago, said, "I am hoping we are finally seeing channels opening and that this will be the first of many new drugs to hit the market [for sickle cell disease]."
And it appears Dr. Thompson's hope is indeed on its way to becoming reality. For one thing, SCD-101, our own new drug for sickle cell, is currently undergoing clinical trials. So far, the response has been highly encouraging -- the "Blood" journal has recognized SCD-101's ability to reduce cell sickling, increase exercise ability, and improve sleep and ulcer healing. And, as of yet, there have been no side-effects discovered. Even better, the supplement form of SCD-101 known as Xickle is available for use now.
Nature.com reports that a slew of other sickle cell drugs are in development now, as well, which is incredibly encouraging. Having options for sickle cell treatment is important for many reasons: Every person's body does not react to every drug in the same way and certain health insurance plans may only cover certain sickle cell drugs, just to name a couple.
This is just the beginning of a potentially huge deluge of breakthroughs and treatments for sickle cell -- treatments that can ensure that warriors of all ages receive the medicines they need to live long, healthy, happy, lives.
It's been two years since we first announced we'd be launching clinical trials for SCD-101, the drug equivalent of our supplement Xickle RBC-Plus. A necessary part of our journey toward FDA-approval, the initial phase of our clinical trial has already demonstrated the effectiveness of Xickle on patients with sickle cell disease.
In fact, in the December 2016 issue of Blood, the American Society of Hematology’s weekly medical journal, an article was published illustrating the initial successes of our trial. The feature, “SCD-101: A New Anti-Sickling Drug Reduces Pain and Fatigue and Improves Red Blood Cell Shape in Peripheral Blood of Patients with Sickle Cell Disease,” points out that participants in phase one of the trial not only showed reduced occurrences of cell sickling, but also reported an increase in exercise ability, as well as improved sleep and ulcer healing, leading the researchers to conclude that SCD-101 is a “promising new drug for the treatment of sickle cell disease.”
Fast forward a few months, and because of the success of the initial round, we are now preparing to enter the next phase in our dose-escalation study: a randomized, double-blind, placebo-controlled crossover. Here’s how it’ll work: Participants will be randomized to two treatments—placebo and SCD-101. Some will receive 28 days of the placebo first, followed by 28 days of SCD-101, while others will receive the drug first, followed by the placebo. This method helps compare the two treatments using a relatively small sample size. To ensure accuracy, a 28-day “washout” period—when clinical trial participants are completely taken off a study treatment for a set amount of time—will follow each 28-day treatment period. This just guarantees that there will be no “carry-overs” or leftover effects of the first treatment into the second one.
This next phase of the trial will continue to test the safety and effectiveness of escalating doses of SCD-101—things like changes in sleep and exercise activity, pain incident and pain reliever usage, fatigue symptoms, and of course, sickling frequency. We expect to continue to see positive reactions from sickle cell warrior participants.
The best news, though? While FDA approval for the official drug development of SCD-101 may take another four years, you can purchase and use SCD-101 in its supplement form, Xickle RBC-Plus. With no known toxicity, Xickle helps prevent sickling in both children and adults. Why wait to get started?
For even more info on Xickle RBC-Plus/SCD-101, check out the video below:
New Year, new look doesn't just mean stocking your closet, home, and makeup bag with fresh finds. We at xickle.com also took the dawning of 2017 as a cue for a major upgrade. And we did it all with you in mind.
An experience that's much more aesthetically pleasing? We've got that. A collection of articles that's easier to navigate than ever before? Yep, we've got that, too. Plus, you can now connect with us on Twitter and Facebook just by clicking the icons we've integrated into the site.
But even more importantly, our redesign calls attention to what matters to you most: How Xickle RBC-Plus will actually help sickle cell warriors like you, your family, and your friends. The new homepage, for example, greets you with important information from our recent clinical study presented last month at the American Society of Hematology's annual conference (and also published the the ASH's journal "Blood"). A study that led Dr. Peter N. Gillette -- director of the adult sickle cell program at Downstate Medical Center in New York -- to conclude that “SCD-101 [the drug equivalent of Xickle RBC-Plus] is a promising new drug for the treatment of sickle cell disease, based on the results from the studies reported here ... Clinical benefits included reduced chronic pain and fatigue, improved sleep and improved ulcer healing." The new homepage also provides a look at testimonials and gives easy access to links where you can learn more about the product, our story, and sickle cell news in general.
"We want to let people with sickle cell disease know there's hope," explains Dr. Eric Coles, Xickle's CEO.
So, what are you waiting for? Check out some of our most popular posts below and experience our new design for yourself!
For almost a year, we've been in the process of conducting Phase I of our clinical trial -- the first step on Xickle's journey toward FDA approval. This first phase -- a dose-escalation study -- involved participants with sickle cell taking oral doses of SCD-101, the drug-equivalent of Xickle RBC-Plus.
Based on the development of herbal medications like Niprisan, SCD-101 is comprised of a proprietary blend of sorghum, pepper, and clove extracts, and is the newly improved formulation of the original Xickle RBC-Plus. This strengthened composition is set to be released the first of the year (2017), and the clinical evidence we've discovered so far is nothing short of promising.
Our clinical trial participants have reported reduced chronic pain and fatigue, as well as improved sleep and ulcer healing. And we've observed a direct anti-sickling effect on red blood cells that is twice the anti-sickling activity of the initial supplement.
For all the details on our clinical trial and its findings, check out our recent presentation for the American Society of Hematology. Phase II of our trial will begin in 2017.
Xickle RBC-Plus/SCD-101 can protect the structural integrity of red blood cells and can reduce the occurrence of red blood cell clumping. To take advantage of these benefits, visit our website and place your order.
Wishing you all much health and happiness in the new year!
