Restless Legs Syndrome Foundation Blog

SANTA CLARA, Calif.--(BUSINESS WIRE)-- XenoPort, Inc. (Nasdaq: XNPT) announced today that shipments of Horizant^® (gabapentin enacarbil) Extended-Release Tablets to its distributor in the United States have commenced. Depending on individual pharmacy ordering patterns, the product is anticipated to be generally available to patients in the first week of June.
“We are pleased that the issues related to manufacturing have been resolved and that product has now been shipped to our distribution center, which will be filling orders from wholesalers shortly,” commented Ronald W. Barrett, Ph.D., chief executive officer of XenoPort. “We have received inquiries from patients and physicians about the status of Horizant, hence our desire to make today’s announcement.”

On May 1, 2013, XenoPort re-acquired from GlaxoSmithKline (GSK) all commercialization rights to Horizant. Prior to the reacquisition of Horizant, GSK experienced manufacturing issues and delays that have resulted in a stockout of the product.

About Horizant (gabapentin enacarbil)
Gabapentin enacarbil is a patented molecule that was discovered and developed by XenoPort. It utilizes XenoPort’s Transported Prodrug technology that was designed to take advantage of high-capacity transport mechanisms in the gastrointestinal tract to offer efficient absorption and extended exposure of gabapentin. (Horizant is not interchangeable with other gabapentin products.)

About XenoPort
XenoPort, Inc. is a biopharmaceutical company focused on developing and commercializing a portfolio of internally discovered product candidates for the potential treatment of neurological disorders. Horizant, XenoPort’s internally discovered drug, is approved and being marketed by XenoPort in the United States. Regnite® (gabapentin enacarbil) Extended-Release Tablets is approved and is being marketed in Japan. Astellas Pharma Inc. holds all development and commercialization rights for Regnite in Japan and five other Asian countries. XenoPort holds all other world-wide rights to gabapentin enacarbil. XenoPort's pipeline of product candidates includes potential treatments for patients with spasticity, Parkinson's disease, relapsing-remitting multiple sclerosis and psoriasis.

Forward-Looking Statements
This press release contains “forward-looking” statements, including, without limitation, all statements related to the availability of Horizant to patients and the timing thereof. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “anticipated,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon XenoPort's current expectations. Forward-looking statements involve risks and uncertainties. XenoPort's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to XenoPort’s lack of commercialization experience and its ability to establish, or contract with third parties to establish, distribution, manufacturing, supply chain and other sufficient capabilities to manufacture and distribute Horizant and XenoPort’s ability to obtain uninterrupted drug supply. These and other risk factors are discussed under the heading “Risk Factors” in XenoPort’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2013, filed with the Securities and Exchange Commission on April 24, 2013. XenoPort expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Horizant, Regnite and XENOPORT are registered trademarks of XenoPort, Inc.
XNPT2G

Source: XenoPort, Inc.
View this news release online at:
http://www.businesswire.com/news/home/20130517005141/en

A shortage of Horizant continues to impact the WED/RLS community. A medication approved by the FDA in 2011 to treat WED/RLS symptoms, Horizant (gabapentin enacarbil) has been in short supply since April due to manufacturing delays. Drug developer XenoPort Inc. said it hopes a new stock of Horizant will be in pharmacies in June, but the timing is uncertain. To find the link to the story on our website, click here. You can also read the Xenoport press release on the subject.

In about 1998, my eight-year-old granddaughter and I were camping in New Hampshire. It was cold and rainy, so we spent quite a bit of the time huddled in our pop-up camper. I just wanted to bundle up in my sleeping bag and take a nap. But there was no rest for me! My granddaughter said, “I’m sorry, Mimmi,” as she witnessed my struggle for rest. I knew then that I needed to visit my doctor.

Thank goodness my doctor told me I had restless legs syndrome (now called Willis-Ekbom disease, or WED/RLS) and not some psychiatric problem. However, he prescribed Sinemet. Oh, that first night’s sleep was “delicious!” But before long, I found that I could not sit through a meeting at work without swinging my legs under the table. My daughter began searching the Internet, and found that Sinemet, as we all now know, has the serious side effect of augmentation. I educated my doctor about this and he prescribed Requip, which worked well for several years. When Requip no longer controlled my symptoms, my doctor changed my prescription to Mirapex.

Meanwhile, both my daughters began to experience the symptoms of restless legs syndrome. My son is still fighting for sleep without benefit of medications. They all say, “Thanks, Ma,” for my role in their inheriting this life-changing problem.

In 2003, I became a support group leader for the RLS Foundation (now the WED Foundation) and have been active with creating awareness, offering support and educating others in my area ever since. Understanding and coping with WED/RLS has been a journey of a lifetime for me, for my communities of friends and church, and for my family.

The hospital experience
In the fall of 2011, my doctor diagnosed me with rectal carcinoma with neuroendocrine features, an extremely rare form of cancer. Even at the University of Texas MD Anderson Cancer Center, a
premier cancer institute, they had a difficult time with the specific diagnosis. When the doctor talked to us about it, he said there is so little known about it that the treatment would be for ordinary rectal cancer. Isn’t that a scary thought?

The story about my initial hospitalization on February 15, 2011, at MD Anderson is still fresh in my mind. Before the surgery, I had a detailed discussion with my anesthesiologist and provided him with the Foundation’s Surgery and RLS brochure. After the surgery, I was on pain meds, so my WED/RLS seemed to be under control. However, when the pain meds were reduced, suddenly there were those creepy-crawly feelings in my legs. The hospital stocked Mirapex, but they refused to give me any extra to “get ahead” of those familiar feelings. I asked to walk so many times that the nurses began to tell me, “No more walking. You’ve got to stay in bed and stay still.” If they’d only known the extent of my anguish! Finally, I asked to be given Sinemet (carbidopa/levodopa) at about 2:00 p.m. along with my Mirapex at night. Only then did I get some rest.

Unfortunately, that’s not the end of the story. When I returned to our little “cottage in the woods” in Maine, I soon developed a blocked bowel, which called for another big surgery. Again, I had a long discussion with this anesthesiologist and provided him the Surgery and RLS brochure. This surgery resulted in a near shutdown of my kidneys – a real nightmare. This time, the hospital stocked Mirapex in the pharmacy, but not Sinemet. My husband brought my Sinemet and gave it to the nursing staff, and they freely gave me a dose every day at 2:00 p.m.

The lessons learned are: 1) Take your WED/RLS prescriptions from your doctor to the hospital before the date for your surgery. 2) To help educate hospital staff, bring related WED/RLS brochures with you on the date you are admitted.

Recording your stories
One of my passions is writing stories that record memories of my family. This began many years ago when my most beloved father-inlaw began to tell me wonderful stories of his childhood growing up in a small farming community in central Texas. I wrote them down on scraps of paper, backs of envelopes, etc. When I was requested to submit my stories to a new history book for the county that included his community, I gathered all my notes and pictures for the submission, carefully noting that the stories were told to me by my
father-in-law. Now those stories and pictures are included in the big red history book for Grimes County, Texas. I read them to my grandchildren so they will know a little about their heritage.

With cancer threatening to shorten my life, I feel a real urge to complete all my stories. An important part of telling my stories is to write about living with restless legs syndrome so future generations can read about my journey of coping with a disease that is still underdiagnosed and misunderstood. I have given my stories as gifts to my children, my grandchildren and my sisters. These stories are my legacy.

Sally Breen was born in Brownsville, Texas, spent time in Colorado Springs, Colorado, returned to Texas in 1979, and now lives in Windham, Maine. She has happy memories of raising her three children, of her work towards a nuclear-weapons-free-world, and a life full of adventure traveling in Central America.