Internet Terms of Use

Welcome to our Web site. Arbor Pharmaceuticals, LLC, Inc owns, controls and maintains this site for your information and education and as a service to the Internet community. Through your access to information or materials on this Web site, you acknowledge certain of our intellectual property rights and you accept, without limitation or qualification, to be bound by the Terms of Use set forth below that supersede any other agreement between you and Arbor Pharmaceuticals covering our Web site or the contents of the Web site. We reserve the right to change these Terms of Use from time to time at our sole discretion and without notice, and such changes shall become effective when posted on the Web site.

The product information provided on our Web site is intended for residents of the United States.

ATTENTION: PLEASE READ THESE TERMS OF USE CAREFULLY BEFORE USING THIS WEB SITE. BY USING THIS WEB SITE, INCLUDING ANY SERVICES PROVIDED ON OR THROUGH THIS WEB SITE (WWW.HORIZANT.COM) YOU INDICATE THAT YOU ACCEPT, WITHOUT LIMITATION OR QUALIFICATION, THESE TERMS OF USE. IF YOU DO NOT ACCEPT THESE TERMS OF USE, DO NOT USE THIS WEB SITE.

Forward-Looking Statements
This Web site contains "forward-looking" statements within the meaning of the federal securities laws, specifically the Securities Litigation Reform Act of 1995, including, without limitation, statements related to the continued development and clinical, therapeutic and commercial potential of, and opportunities for, HORIZANT®; future periods; future events; and future operating and financial plans and performance. For this purpose, any statements contained in this Web site that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "anticipates," "believes," "could," "estimates," "expects," "forecast," "goal," "intends," "may," "objective," "outlook," "plans," "potential," "predict," "project," "should," "will," "would" and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause our results, performance, time frames or achievements to differ materially from those indicated, expressed or implied by these forward-looking statements. We disclaim any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained on this Web site to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

Limited License

All contents on our Web site, including, but not limited to, pictures, illustrations, designs, icons, text, audio clips, and video clips (collectively, the "Site Content") and all intellectual property rights therein, are owned, controlled, or licensed by Arbor Pharmaceuticals, LLC, our affiliates or partners or other individuals or organizations and are protected by copyright. You may view and make a reasonable number of copies of materials made available on the public portions of our Web site solely for non-commercial, personal and informational purposes. You may not publicly distribute information or materials made available on the Web site, and no use of the Web site or the information therein is authorized other than the use expressly described in these Terms of Use. Any copy you make of this material or information shall retain all copyright and other proprietary notices in the same form and manner as on the original. Except as specified above, nothing contained in this Web site shall be construed as conferring by implication, estoppel or otherwise, any license or right under any copyright, patent, trademark or other intellectual property right of Arbor Pharmaceuticals or any third party. No other use of the information is authorized without the express written permission of Arbor Pharmaceuticals or the copyright owner. All other rights reserved.

User-Provided Ideas

Arbor Pharmaceuticals, LLC does not accept or consider unsolicited ideas submitted through, or in connection with, the Web site. Notwithstanding the foregoing, you agree that any feedback, information, suggestions, ideas or materials (e.g., text, photographs, caricatures, illustrations, designs, icons, articles, audio clips, and video clips, etc.) you submit through, or in connection with, this Web site (each an "idea") will not be subject to any use or disclosure restrictions and will be considered non-confidential by us. By providing ideas to us, you agree that we shall have, at no charge, a non-exclusive, transferable, royalty-free, perpetual, irrevocable, worldwide right and license to reproduce, distribute, display, perform and create derivative works of such ideas and to use, make, offer for sale, sell and import products containing or based on such ideas. We shall be free to use and disseminate such ideas on an unrestricted basis for any purpose. In addition, we do not control ideas posted or otherwise transmitted via this Web site by others and we do not guarantee the accuracy, integrity, or quality of such ideas. Any communications you send to this Web site or otherwise to Arbor Pharmaceuticals by electronic mail, with the exception of personally identifiable information as defined in the Arbor Pharmaceuticals Internet Privacy Statement shall be deemed to be non-confidential.

Privacy

Our policies concerning the use of your personal information are set forth in the Arbor Pharmaceuticals, LLC Internet Privacy Statement on this Web site and incorporated by reference herein. By using this Web site or the services provided by or through this Web site ("services"), you agree to waive and release Arbor Pharmaceuticals from any claim or liability in connection with the collection, use, or disclosure of information consistent with the Arbor Pharmaceuticals Internet Privacy Statement.

Medical Advice
The Site Content is provided for informational purposes only and should not be construed as medical, legal, financial, investment, or other professional advice or opinion. We do not offer personalized medical advice or patient-specific treatment advice. Only your doctor or other healthcare professional can determine if a product described on this Web site is appropriate for you. Use of this Web site is not a substitute for a call or visit to, or consultation with, your physician or a healthcare professional. You should not rely on this Web site or any other service offered by or through this Web site for medical diagnosis or treatment. YOU SHOULD NEVER DISREGARD OR DELAY SEEKING MEDICAL ADVICE BECAUSE OF SOMETHING THAT YOU HAVE SEEN OR HEARD ON THIS WEB SITE. PLEASE CONSULT WITH YOUR DOCTOR, OR OTHER QUALIFIED HEALTHCARE PROFESSIONAL, BEFORE USING ANY PRODUCT DISCUSSED ON THIS WEB SITE.

Disclaimers

The Site Content is for your general education only and is not intended to provide advice or guidance or to be used for any commercial purpose. The identification or description of products or services of Arbor Pharmaceuticals, LLC or third parties on the Web site is for informational purposes only and does not constitute a representation, warranty, guarantee, endorsement or recommendation of such products and services. Although we have attempted to provide accurate information on our Web site, we assume no responsibility for the accuracy of the Site Content. In particular, we may not update our Web site on a daily or other regular basis. As such, the Site Content may be out of date or include omissions or other errors. We may update or change the Site Content at any time without notice.

All Site Content is provided "AS IS" and "AS AVAILABLE" without warranty of any kind. To the maximum extent permitted by law, Arbor Pharmaceuticals, LLC, its affiliates and its collaborators disclaim all warranties, express or implied, regarding the Web site and the Site Content therein, including the implied warranties of merchantability, fitness for a particular purpose, and non-infringement of third-party rights.

We make no warranty that this Web site will meet your requirements; that this Web site will be uninterrupted, timely, secure, or error free; that messages or requests will be delivered; that defects will be corrected; or that this Web site is free of viruses or other harmful components. We make no warranty regarding any goods or services purchased or obtained through this Web site or any transactions entered into through this Web site. You assume the entire risk as to the results and performance of this Web site and any goods or services purchased therefrom.

Limitation of Liability
You agree to indemnify, defend and hold harmless Arbor Pharmaceuticals, LLC, its subsidiaries, affiliates, directors, officers, employees, agents, consultants, business partners and assigns of same from and against any and all loss, costs, expenses (including reasonable attorneys' fees and expenses), claims, damages and liabilities related to, or associated with, your use of this Web site and any hyperlinked Web site or based on any reliance upon the information contained therein and any violation of these Terms of Use by you. Applicable law may not allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you.

Use of this Web Site
You agree not to do any of the following while visiting or using this Web site or any services provided by or through this Web site:

Arbor Pharmaceuticals, LLC may, at its sole discretion, take any action we deem necessary, including, but not limited to, termination of access to this Web site, if we believe a user's conduct or content fails to conform to the terms and conditions provided in these Terms of Use or may create liability for Arbor Pharmaceuticals, our affiliates, partners, suppliers or other users. Arbor Pharmaceuticals will not be liable to you or any third party as a result of such termination and modification. The terms and conditions provided in the Terms of Use will survive any such termination and modification.

Hyperlinks
Our Web site may contain hyperlinks to Web sites owned and/or controlled by other parties. When you are leaving our Web site, we use the following symbol [ ] to indicate that you are leaving our Web site. Access to any other Web site is at your own risk, and we are not responsible for the accuracy or reliability of any information, data, opinions, advice or statements accessible from these Web sites, and we do not make any representations or warranties about them. Third-party linked Web sites and their contents should not be attributed to Arbor Pharmaceuticals, LLC in any manner. We provide these hyperlinks merely as a convenience, and the hyperlinks are not an endorsement of any product, service, individual, or entity.

Governing Law and Jurisdiction
We reserve our right to any remedy available at law or equity in the event of your breach of these Terms of Use. All matters arising from, or related to, these Terms of Use and your access to, or use of, the Web site shall be governed by U.S. federal law. You agree that you will bring any legal action or proceeding arising from, or relating to, your access to, or use of, the Web site exclusively in a state court in Santa Clara County, California, or in the U.S. district court for the Northern District of California. You agree to submit to the jurisdiction of, and agree that venue is proper in, such courts in any such legal action or proceeding.

Reservation
Any rights not expressly granted in our Web site are reserved to us. If any provision of these Terms of Use is held to be invalid or unenforceable, such provision shall be struck and the remaining provisions shall be enforced.

Trademarks
"Arbor Pharmaceuticals, LLC," the Arbor Pharmaceuticals logo, and HORIZANT® are registered trademarks of Arbor Pharmaceuticals. Any use of "Arbor Pharmaceuticals" except as permitted herein is prohibited and may be in violation of trademark law and other laws. All trademarks, logos, trade names, trade dress, service marks and products of Arbor Pharmaceuticals ("Marks") displayed on our Web site are the property of Arbor Pharmaceuticals or third parties, are protected in the United States and internationally and may not be used for advertising or publicity purposes, or to indicate any affiliation with, or endorsement by, Arbor Pharmaceuticals. These Marks may not be used in whole or in part without the prior written permission of such owners.

This Web Site is for U.S. Audiences Only
Access to, and use of, this Web site is subject to the above Terms of Use. This Web site was developed and is maintained by Arbor Pharmaceuticals. This information is intended only for residents of the United States.

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INDICATIONS

HORIZANT® (gabapentin enacarbil) Extended-Release Tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults. HORIZANT is not recommended for patients who are required to sleep during the daytime and remain awake at night.

HORIZANT® (gabapentin enacarbil) Extended-Release Tablets are indicated for the management of postherpetic neuralgia (PHN) in adults.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Effects on Driving
HORIZANT may cause significant driving impairment. The duration of driving impairment after starting therapy is unknown. Patients should not drive until they have enough experience on HORIZANT to know if it impairs their driving. Patients’ ability to assess their driving competence and degree of somnolence caused by HORIZANT can be imperfect.

Somnolence/Sedation and Dizziness
HORIZANT causes somnolence/sedation and dizziness. Patients should not drive or operate other complex machinery until they have enough experience on HORIZANT to know if it impairs their ability to perform these tasks.

Lack of Interchangeability With Gabapentin
HORIZANT is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles. The same dose of HORIZANT results in different plasma concentrations of gabapentin relative to other gabapentin products. The safety and effectiveness of HORIZANT in patients with epilepsy have not been studied.

Suicidal Behavior and Ideation
HORIZANT is a prodrug of gabapentin, an antiepileptic drug (AED). AEDs increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. As a prodrug of gabapentin, HORIZANT also increases this risk. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Anyone considering prescribing HORIZANT must balance the risk of suicidal thoughts or behavior with the risk of untreated illness.

Patients, caregivers, and families should be informed that HORIZANT increases the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts of self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has been reported in patients taking antiepileptic drugs, including gabapentin. HORIZANT is a prodrug of gabapentin. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its expression, other organ systems not noted here may be involved.

It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. HORIZANT should be discontinued if an alternative etiology for the signs or symptoms cannot be established.

Discontinuation of HORIZANT
When discontinuing HORIZANT, patients with RLS receiving 600 mg or less once daily can discontinue the drug without tapering. If the recommended dose is exceeded, the dose should be reduced to 600 mg daily for 1 week prior to discontinuation to minimize the potential of withdrawal seizure.

In patients with PHN receiving HORIZANT twice daily, the dose should be reduced to once daily for 1 week prior to discontinuation to minimize the potential of withdrawal seizure.

Tumorigenic Potential
In an oral carcinogenicity study, gabapentin enacarbil increased the incidence of pancreatic acinar cell adenoma and carcinoma in male and female rats. The clinical significance of this finding is unknown.

ADVERSE REACTIONS
The most common adverse reactions for patients with RLS (incidence >10% and at least 2 times the rate of placebo) were somnolence/sedation and dizziness.

The most common adverse reactions for patients with PHN (incidence >10% and greater than placebo) were dizziness, somnolence, and headache.

DRUG INTERACTIONS
Gabapentin enacarbil is released faster from HORIZANT Extended-Release tablets in the presence of alcohol. Consumption of alcohol is not recommended when taking HORIZANT.

HORIZANT taken in conjunction with morphine causes increased somnolence/sedation, dizziness, and nausea.

USE IN SPECIAL POPULATIONS

Pregnancy and Lactation
Pregnancy Category C. There are no adequate and well-controlled studies with HORIZANT in pregnant women. In nonclinical studies in rat and rabbits, administration of gabapentin enacarbil was developmentally toxic when administered to pregnant animals at doses and gabapentin exposures greater than those used clinically. HORIZANT should be used during pregnancy only if potential benefit justifies potential risk to fetus.

It is not known whether gabapentin derived from HORIZANT is secreted in human milk; however, gabapentin is secreted into human milk following oral administration of gabapentin products. Because of the potential for adverse reactions in nursing infants from HORIZANT, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use
Safety and effectiveness of HORIZANT in pediatric patients have not been studied.

Renal Impairment
Gabapentin is known to be almost exclusively excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. The dose of HORIZANT should be adjusted in patients with renal impairment based upon creatinine clearance. HORIZANT is not recommended for treatment of RLS in patients receiving hemodialysis.

For additional safety information, consult the HORIZANT full Prescribing Information here.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

VIEW FULL IMPORTANT SAFETY INFORMATION

Effects on Driving
HORIZANT may cause significant driving impairment. The duration of driving impairment after starting therapy is unknown. Patients should not drive until they have enough experience on HORIZANT to know if it impairs their driving. Patients’ ability to assess their driving competence and degree of somnolence caused by HORIZANT can be imperfect.

Somnolence/Sedation and Dizziness
HORIZANT causes somnolence/sedation and dizziness. Patients should not drive or operate other complex machinery until they have enough experience on HORIZANT to know if it impairs their ability to perform these tasks.

 

References

  1. Horizant [prescribing information]. Atlanta, GA: Arbor Pharmaceuticals, LLC.

  2. Cundy KC, Sastry S, Luo W, Zou J, Moors TL, Canafax DM. Clinical pharmacokinetics of XP13512, a novel transported prodrug of gabapentin. J Clin Pharmacol. 2008;48(12):1378-1388.

  3. Neurontin® [prescribing information]. New York, NY. Pfizer® Inc.

  4. Data on file. Arbor Pharmaceuticals, LLC.

  5. Zhang L, Rainka M, Freeman R, et al. A randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of gabapentin enacarbil in subjects with neuropathic pain associated with postherpetic neuralgia (PXN110748). J Pain. 2013;14(6):590-603.

  6. Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94(2):149-158.

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