Healthcare Industry News: OMNARIS
News Release - March 17, 2008
Sepracor Presents Safety Data on OMNARIS(TM)AQ and OMNARIS(TM) HFA Nasal Sprays at American Academy of Allergy Asthma and Immunology (AAAAI)Ciclesonide is a corticosteroid with a unique activation mechanism and is a prodrug activated by intracellular esterases following oral or nasal inhalation
Study demonstrates low systemic bioavailability of ciclesonide in both formulations, OMNARIS aqueous (AQ) Nasal Spray and OMNARIS hydrofluoroalkane (HFA)
OMNARIS AQ Nasal Spray is on track to be launched in April 2008
The U.S. market for nasal corticosteroids is estimated at approximately $2.3 billion(1)
MARLBOROUGH, Mass.--(HSMN NewsFeed)--Sepracor Inc. (Nasdaq: SEPR ) announced today that new data were presented that reinforce prior research findings regarding the low systemic bioavailability of ciclesonide, the active ingredient in OMNARIS (ciclesonide) AQ Nasal Spray, a product approved by the U.S. Food and Drug Administration, and is indicated for the treatment of nasal symptoms associated with seasonal and perennial allergies. These new data were presented at the AAAAI 2008 annual meeting held in Philadelphia, PA.
In this study, ciclesonide AQ nasal spray and ciclesonide HFA metered-dose inhaler (MDI), a nasal aerosol formulation of ciclesonide expected to enter Phase III development in the second half of 2008, both demonstrated low systemic bioavailability when compared with orally inhaled ciclesonide HFA MDI.
Ciclesonide AQ and ciclesonide HFA nasal sprays both contain the active ingredient ciclesonide, a unique corticosteroid that is activated after administration into des-ciclesonide, which has potent anti-inflammatory activity and a high affinity for glucocorticoid receptors. Ciclesonide and des-ciclesonide have negligible bioavailability due to low gastrointestinal absorption and first pass metabolism.
“These study results further our understanding of ciclesonide and its unique properties,” said Mark H.N. Corrigan, M.D., Executive Vice President, Research and Development at Sepracor. “Low bioavailability means that the drug acts where it’s supposed to - in this case, the nasal passage - to relieve inflammation that is the root cause of nasal allergy symptoms, such as congestion. This study demonstrates minimal amounts of the drug entering the blood stream, limiting the potential for systemic side effects associated with steroids.”
Ciclesonide AQ is on track to be launched in April 2008 as OMNARIS AQ Nasal Spray. OMNARIS AQ Nasal Spray is formulated in a unique hypotonic solution, which may reduce the drug’s run-off down the back of the throat and enhance the ability of the compound to adhere to the mucosal surface. Intranasal corticosteroids are well accepted as first-line therapy for the treatment of allergic rhinitis.
About the Data
Poster 205 Low Systemic Bioavailability of Ciclesonide AQ Nasal Spray and Ciclesonide HFA Nasal Aerosol Compared With Orally Inhaled Ciclesonide
- Thirty healthy volunteers at least 18 years of age were randomized in an open-label, single-dose, 3-period crossover study to ciclesonide AQ nasal spray 300 mcg, ciclesonide HFA nasal aerosol 300 mcg, or ciclesonide orally inhaled HFA MDI 320 mcg.
- Primary pharmacokinetic parameters were area under the serum concentration time curve extrapolated to infinity (AUCinf) and maximum serum concentration (Cmax) of des-ciclesonide. The safety and tolerability of ciclesonide were also evaluated.
- The systemic bioavailability of des-ciclesonide, the active metabolite of ciclesonide, was 10-fold lower for ciclesonide HFA and at least 30-fold lower for ciclesonide AQ nasal spray compared with the orally inhaled HFA MDI formulation of ciclesonide.
- These pharmacokinetic data support the conclusion that systemic exposure to the steroid ciclesonide is many-fold higher for the orally inhaled HFA MDI formulation than for either nasal preparation.
Allergic rhinitis is a chronic inflammatory disease of the nasal mucosa causing sneezing, itching, nasal congestion and discharge.2A Some patients with allergic rhinitis have systemic symptoms, including weakness, malaise, irritability, fatigue, difficulty concentrating and decreased appetite.2B
Allergic rhinitis is the most common allergic disease in the U.S. affecting about 40 million people, specifically 10 to 30 percent of adults and up to 40 percent of children.3 It is associated with direct costs of about $4.5 billion annually and indirect costs that reflect approximately four million days of lost time and productivity at work and school.4
Seasonal allergic rhinitis is caused by substances typically outdoors (i.e., pollen) that set off allergies and is sometimes referred to as “hay fever.” Symptoms may vary in occurrence and intensity during the day or from season to season. Symptoms are often worse in the morning even when the exposure occurred on the previous day.2C
Perennial allergic rhinitis is a chronic condition caused by triggers such as pet dander and dust. Symptoms of perennial allergic rhinitis are very similar to those of seasonal allergic rhinitis, although perennial is persistent and chronic.2C
Ciclesonide is a corticosteroid with a unique activation mechanism. It is a prodrug that is activated by intracellular esterases following oral or nasal inhalation.
OMNARIS (ciclesonide) AQ Nasal Spray is the intranasal formulation of ciclesonide for the treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older, and with perennial allergic rhinitis in adults and adolescents 12 years of age and older. Intranasal corticosteroids are well accepted as first-line therapy for the treatment of allergic rhinitis, and they work by reducing inflammation - the major underlying cause of the clinical symptoms. Ciclesonide nasal spray was shown to have a favorable safety profile. The most frequently reported adverse events seen with ciclesonide nasal spray were headache, epistaxis, nasopharyngitis, ear pain, and pharyngolaryngeal pain. The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency. Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients.
Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease by discovering, developing and commercializing innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor's drug development program has yielded a portfolio of pharmaceutical products and candidates with a focus on respiratory and central nervous system disorders. Currently marketed products include LUNESTA® brand eszopiclone, XOPENEX® brand levalbuterol HCl Inhalation Solution, XOPENEX HFA® brand levalbuterol tartrate Inhalation Aerosol and BROVANA® brand arformoterol tartrate Inhalation Solution. Sepracor's corporate headquarters are located in Marlborough, Massachusetts.
This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the development, commercialization and distribution of products containing ciclesonide; the planning of Phase III studies of OMNARIS HFA in the second half of 2008; and the expected launch of OMNARIS AQ in April 2008. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: the clinical benefits, efficacy and safety of products containing ciclesonide; the timing and success of the development of products containing ciclesonide; unexpected delays in commercial introduction and the commercial success of products containing ciclesonide; the ability of Nycomed GmbH to supply or obtain from third parties Sepracor's requirements for products or components covered by Sepracor’s exclusive distribution and development agreement with Nycomed; the success of Sepracor's alliance with Nycomed; the scope of Nycomed’s and/or Sepracor’s patents and the patents of others; the ability of Sepracor and Nycomed to attract and retain qualified personnel; and certain other factors that may affect future operating results that are detailed in Sepracor’s annual report on Form 10-K for the year ended December 31, 2007 filed with the Securities and Exchange Commission.
In addition, the statements in this press release represent Sepracor's expectations and beliefs as of the date of this press release. Sepracor anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while Sepracor may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Sepracor's expectations or beliefs as of any date subsequent to the date of this press release.
1 IMS Health, moving average total for nasal corticosteroids as of December 2007.
2A American Academy of Allergy, Asthma and Immunology (AAAAI). [Internet]. The Allergy Report. Available from: http://www.aaaai.org/ar/default.stm. Accessed: Feb. 18, 2008. Volume 2. Page 1.
2B American Academy of Allergy, Asthma and Immunology (AAAAI). [Internet]. The Allergy Report. Available from: http://www.aaaai.org/ar/default.stm. Accessed: Feb. 18, 2008. Volume 2. Page 10.
2C American Academy of Allergy, Asthma and Immunology (AAAAI). [Internet]. The Allergy Report. http://www.aaaai.org/ar/default.stm. Accessed: Feb. 18, 2008. Volume 2. Page 12.
3 American Academy of Allergy, Asthma and Immunology (AAAAI). [Internet]. The Allergy Report. Available from: http://www.aaaai.org/ar/default.stm. Accessed: Feb. 18, 2008. Volume 1. Page 1.
4 Round table discussion. The health and economic impact of rhinitis. Am J Main Care 1997; 3: S8-18. Page S11. Figure 1.
OMNARIS is a trademark of Nycomed GmbH. Lunesta, Xopenex, Xopenex HFA and Brovana are registered trademarks of Sepracor Inc.
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