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Laboratorios SALVAT S.A. and Arbor Pharmaceuticals, LLC Announce the Launch of OTOVEL® (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) otic solution

08/31/16

BARCELONA, Spain and ATLANTA, Aug. 29, 2016 /PRNewswire/ -- Laboratorios SALVAT S.A. (SALVAT) and Arbor Pharmaceuticals, LLC (Arbor) jointly announce the launch of OTOVEL® (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) otic solution, the first and only antibiotic and steroid combination ear drop available in sterile, preservative-free single-dose vials. OTOVEL® is owned by SALVAT, and Arbor will be the exclusive distributor of the product in the U.S.

"We are very pleased to be partnering with SALVAT to represent OTOVEL® in the U.S.," said Ed Schutter, President and CEO of Arbor. "OTOVEL® is a perfect fit with our other pediatric products that are sold by our team of over 200 sales professionals throughout the country."

"It is exciting to further expand the international commercial availability of OTOVEL® through the partnership with Arbor in the U.S.," said Alberto Bueno, CEO of SALVAT. "This new launch of OTOVEL® is a major milestone for SALVAT as we continue to grow our presence in the U.S. market."

About OTOVEL®

OTOVEL® (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to S. aureus, S. pneumoniae, H. influenzae, M. catarrhalis, and P. aeruginosa. Two phase 3 multicenter, randomized, double-blind, active-controlled, parallel group trials were conducted to assess the efficacy and safety of OTOVEL® compared to ciprofloxacin otic solution and to fluocinolone acetonide otic solution. In total 662 pediatric patients (aged 6 months to 12 years old) with AOMT were included. In both trials, the OTOVEL® treatment arms showed significantly shorter times to cessation of otorrhea in comparison to both the ciprofloxacin and fluocinolone acetonide alone arms. In Study 1 and Study 2 the median time to cessation of otorrhea in the OTOVEL® group was 3.75 and 4.94 days, respectively, compared to 7.69 and 6.83 days in the ciprofloxacin alone group1.

OTOVEL® is packaged in sterile, single-use vials, with each vial containing a delivery volume of 0.25 mL sterile, preservative-free solution. OTOVEL® is promoted and distributed by Arbor and is now available nationwide.

About Acute Otitis Media with Tympanostomy Tubes (AOMT)

Acute otitis media (AOM) is an inflammation of the middle ear space, behind the eardrum (tympanic membrane), that usually results from infection. The infection often results in fluid accumulation (effusion) within the middle ear, increasing pressure on the eardrum. This pressure can cause fever, ear pain, and problems with hearing in affected patients. Children that have recurrent AOM may have tympanostomy tubes inserted through a small incision in the eardrum to help facilitate drainage of fluid from the middle ear. Approximately 1 million children undergo placement of tubes in the United States every year2. While the insertion of tubes may help reduce the recurrence of AOM, a study reported that 83% of children with tympanostomy tubes in place for 18 months will experience at least one episode of AOMT3. The clinical presentation of AOMT is different than AOM in children with an intact eardrum in that pain and fever are much less common. The most common symptom of AOMT is fluid drainage from the ear (otorrhea).

IMPORTANT SAFETY INFORMATION FOR OTOVEL®

INDICATION

OTOVEL® is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to S. aureus, Streptococcus S. pneumoniae, H. influenzae, M. catarrhalis and P. aeruginosa.

IMPORTANT SAFETY INFORMATION

Contraindications

OTOVEL® is contraindicated in:

  • Patients with known hypersensitivity to fluocinolone acetonide or other corticosteroids, ciprofloxacin or other quinolones, or to any other components of OTOVEL®.
  • Viral infections of the external ear canal, including varicella and herpes simplex infections and fungal otic infections.

Warnings and Precautions

Hypersensitivity Reactions - OTOVEL® should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria and itching. Serious acute hypersensitivity reactions may require immediate emergency treatment.

Potential for Microbial Overgrowth with Prolonged Use - Prolonged use of OTOVEL® may result in overgrowth of non-susceptible bacteria and fungi. If the infection is not improved after one week of treatment, cultures should be obtained to guide further treatment. If such infections occur, discontinue use and institute alternative therapy.

Continued or Recurrent Otorrhea - If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within 6 months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.

Adverse Reactions

Clinical trials experience: the most common adverse events that occurred in >1 patient were, otorrhea, excessive granulation tissue, ear infection, ear pruritus, tympanic membrane disorder, auricular swelling and balance disorder.

For additional safety information, consult the OTOVEL® full Prescribing Information or click the following link http://arborpharma.com/docs/OTOVEL_USPI_Final.pdf.

About SALVAT

Laboratorios SALVAT is a privately owned pharmaceutical group closely identified with technological innovation and strongly committed to R&D. Founded in 1955, SALVAT is headquartered in Barcelona (Spain) and its US subsidiary, SALVAT USA, is located in Miami, FL. SALVAT is present in over 60 countries and keeps strengthening its international presence through the licensing of its own developments. The company launched CETRAXAL® (ciprofloxacin 0.2 %) otic solution in the US in 2009 and received FDA approval for OTOVEL® (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) otic solution in April 2016. Additional information regarding Laboratorios SALVAT and its products is available at www.salvatbiotech.com

About Arbor

Arbor Pharmaceuticals, LLC, headquartered in Atlanta, Georgia, is a specialty pharmaceutical company currently focused on the cardiovascular, neurology, hospital and pediatric markets. The company has over 700 employees including approximately 600 sales professionals promoting its products to physicians, hospitals and pharmacists. Arbor currently markets over twenty-two NDA or ANDA approved products with over 35 more in development.

For more information regarding Arbor Pharmaceuticals or any of its products, visit www.arborpharma.com or send email inquiries to info@arborpharma.com.

https://www.otovel.com/

1. OTOVEL Prescribing Information, Arbor Pharmaceuticals, LLC. 2. Dohar JE. Tympanostomy tubes: not the magic bullet for acute otitis media. http://www.medscape.org/viewarticle/730700. Published October 21, 2010. 3. Ah-Tye C, Paradise JL, Colborn DK. Otorrhea in young children after tympanostomy-tube placement for persistent middle-ear effusion: prevalence, incidence, and duration. Pediatrics. 2001;107:349-350



Laboratorios SALVAT S.A.
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