NextWave Pharmaceuticals Announces Launch of NEXICLON™ XR – First Extended-Release, Once-Daily Clonidine Oral Suspension and Tablet

CUPERTINO, Calif.--(BUSINESS WIRE)--NextWave Pharmaceuticals announced today the launch of NEXICLON^™ XR (clonidine) for the treatment of hypertension. NEXICLON XR provides for once-daily dosing, in suspension and tablet form, to be taken alone or concomitantly with other antihypertensive agents.

“The launch of NEXICLON XR is a milestone for our company”

Clonidine, a centrally acting alpha-adrenergic agonist, is a safe and effective treatment for hypertension that has been available for decades. However, until now there have been no once-daily formulations available. NEXICLON XR is manufactured using the proprietary OralXR+^™extended-release technology through which clonidine is formulated into orally-administered tablets or suspension. The availability of NEXICLON XR in both a liquid oral suspension and scored tablet allows for precise dose titration.

“The launch of NEXICLON XR is a milestone for our company,” said Jay Shepard, president and CEO of NextWave Pharmaceuticals. “These novel formulations of clonidine will provide unique dosing options for patients. We are proud to showcase it as our first FDA-approved drug. Our mission at NextWave is to develop products, such as NEXICLON XR, that address the unmet needs of patients; we are excited about this launch as well as the further development of other extended-release products we have in our pipeline.”

NextWave is collaborating with Tris Pharma, creator of the OralXR+ technology, and manufacturer of NEXICLON XR for NextWave. NEXICLON XR will be available in retail pharmacies starting January 2011. For additional information on NEXICLON XR, please visit www.nexiclonxr.com.

INDICATION

NEXICLON XR (clonidine) Extended‐Release Oral Suspension and NEXICLON XR (clonidine) Extended‐Release Tablets are indicated in the treatment of hypertension. NEXICLON XR may be employed alone or concomitantly with other antihypertensive agents.

IMPORTANT SAFETY CONSIDERATIONS

Contraindications

NEXICLON XR should not be used in patients with known hypersensitivity to clonidine (rash, angioedema).

Warnings and Precautions

Patients should not discontinue therapy without consulting a physician. Dose reduction should be performed gradually over a 2‐ to 4‐day period to avoid withdrawal symptomatology. Rare instances of hypertensive encephalopathy, cerebrovascular accidents, and death have been reported after clonidine withdrawal.

Monitor closely and titrate slowly in patients with severe coronary insufficiency, conduction disturbances, recent myocardial infarction, cerebrovascular disease, or chronic renal failure.

Patients who engage in potentially hazardous activities, such as operating machinery or driving, should be advised of a possible sedative effect of clonidine.

In perioperative use, NEXICLON XR may be administered up to 28 hours prior to surgery and resumed the following day.

Adverse Reactions

There is very little experience with NEXICLON XR in controlled trials. Based on this limited experience, the adverse event profile of NEXICLON XR appears similar to that of immediate‐release clonidine formulation. The most commonly expected adverse reactions are dry mouth, drowsiness, and dizziness.

Drug Interactions

No drug interaction studies have been conducted with NEXICLON XR; however the following have been reported with other oral formulations of clonidine:

Clonidine may potentiate the CNS‐depressive effects of alcohol, barbiturates, or other sedating drugs.
Tricyclic antidepressants may reduce the hypotensive effect of clonidine, necessitating an increase in clonidine dose.
Drugs known to affect sinus node function or AV nodal conduction (e.g., digitalis, calcium channel blockers, and beta‐blockers): There may be additive effects such as bradycardia and AV block.

Use in Specific Populations

Pregnancy Category C. Clonidine is secreted in human milk.

Safety and effectiveness in pediatric patients have not been established.

Dose may need adjustment in patients with renal impairment. Elderly patients may benefit from a lower initial dose.

Please see Full Prescribing Information for additional information.

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.

About Tris Pharma

Tris Pharma is a specialty pharmaceutical company focused on the research and development of drug delivery technologies based products. Through its OralXR+ platform, Tris has pioneered the delivery of sustained release in the liquid, chewable/ODT and strip dosage forms so patients do not have to swallow a pill. Tris’ research, development, and manufacturing facilities are located in Monmouth Junction, New Jersey.

About NextWave Pharmaceuticals

NextWave is an emerging specialty pharmaceutical company primarily focused on the development and commercialization of unique products for the treatment of cardiovascular and CNS diseases, with a pipeline of investigational drug candidates targeted for ADHD and related disorders. More information about NextWave is available at www.nextwavepharma.com.

NEXICLON XR is a trademark of NextWave Pharmaceuticals, Inc.