Introduction
SYNERA, a topical anesthetic patch developed by ZARS Pharma, has been a significant innovation in the field of pain management, particularly for superficial venous access and dermatological procedures. This article will delve into the clinical trials, market analysis, and future projections for SYNERA.
Clinical Trials and Efficacy
Study Design and Objectives
SYNERA has undergone rigorous clinical trials to evaluate its efficacy and safety. These trials were randomized, double-blind, and placebo-controlled, involving adult and geriatric subjects. The primary objective was to assess the degree of dermal analgesia provided by SYNERA before venipuncture and superficial dermatological procedures[1][2][4].
Key Findings
- A 20-minute application of SYNERA consistently provided clinically useful anesthesia for vascular access procedures. Subjects reported significantly lower pain intensity using the Visual Analog Scale (VAS) compared to placebo (5 mm vs 28 mm, P < 0.001)[4].
- SYNERA was found to be highly effective, with 73% of subjects reporting adequate anesthesia compared to 31% with placebo (P = 0.002). Investigators and independent observers also rated SYNERA higher in terms of pain relief[4].
Safety Profile
The clinical trials revealed a favorable safety profile for SYNERA. The most common local reactions were erythema (71%), blanching (12%), and edema (12%), which were generally mild and resolved spontaneously after patch removal. Systemic adverse reactions were rare, with dizziness, headache, nausea, somnolence, and vomiting occurring in less than 1% of subjects[1][2].
Market Analysis
Launch and Distribution
SYNERA was launched in the United States in 2006 by Endo Pharmaceuticals Inc., following its approval by the FDA. It was marketed through Endo's existing hospital sales force, targeting healthcare professionals for both adult and pediatric patients[2].
Acquisition and Current Market Status
In 2011, Galen, a Northern Ireland-based pharmaceutical company, acquired the rights to SYNERA from ZARS Pharma Inc. Galen US, Inc. now markets and sells SYNERA in the United States, focusing on its use in providing local dermal analgesia, especially for children[5].
Market Need and Impact
SYNERA addresses a critical need in pain management, particularly for children who are frequently subjected to multiple superficial venous access procedures such as IV infusions and blood draws. According to published data, children under 15 are hospitalized for an estimated 11.5 million days annually, making SYNERA a valuable asset in pediatric care[2].
Market Projections
Growth Potential
Given its efficacy and safety profile, SYNERA is poised for continued growth in the market. The demand for effective topical anesthetics is increasing, driven by the need for pain-free medical procedures, especially in pediatric and geriatric populations.
Competitive Landscape
SYNERA is the first topical patch approved for the prevention of pain associated with superficial venous access and dermatological procedures, giving it a unique market position. However, the competitive landscape in pain management is dynamic, with new products and technologies emerging. SYNERA's integrated heating component and eutectic mixture of lidocaine and tetracaine provide a competitive edge, but continuous innovation and marketing efforts will be necessary to maintain market share.
Future Developments
As healthcare continues to evolve, there is a growing emphasis on patient comfort and pain management. SYNERA is well-positioned to benefit from these trends. Future developments may include expanded indications, improved formulations, and broader distribution channels, all of which could enhance its market presence.
Key Takeaways
- Efficacy: SYNERA has demonstrated significant efficacy in providing local dermal analgesia for superficial venous access and dermatological procedures.
- Safety: The patch has a favorable safety profile with mild and transient local reactions.
- Market Need: It addresses a critical need in pain management, especially for pediatric patients.
- Market Status: Currently marketed by Galen US, Inc., with a strong potential for growth.
- Future Projections: Expected to continue growing due to its unique features and increasing demand for pain-free medical procedures.
FAQs
What is SYNERA used for?
SYNERA is used for the prevention of pain associated with superficial venous access and superficial dermatological procedures such as excision, electrodessication, and shave biopsy of skin lesions[2].
How long does SYNERA take to provide anesthesia?
SYNERA provides clinically useful anesthesia in as little as 20 to 30 minutes prior to procedures[1][2][4].
What are the common side effects of SYNERA?
The most common side effects include localized reactions such as erythema, blanching, and edema, which are generally mild and resolve spontaneously after patch removal[1][2].
Can SYNERA be used in children?
Yes, SYNERA is indicated for use in patients 4 months of age and older, making it particularly useful for pediatric patients undergoing medical procedures[2].
Who currently markets SYNERA in the United States?
Galen US, Inc. currently markets and sells SYNERA in the United States[5].
Sources
- FDA Label for SYNERA: Access Data FDA.
- Biospace - Synera Launch: Biospace.
- Syndax Announces Pivotal AUGMENT-101 Trial: PR Newswire.
- Use of the Synera patch for local anesthesia: PubMed.
- Galen Acquires Synera: Galen Pharma.
