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DAXXIFY, the first and only peptide formulated neuromodulator, which was approved by the FDA for the temporary improvement of moderate to severe glabellar lines in adults, was evaluated in two Phase 3 clinical studies for cervical dystonia:
Positive results from our
In the pivotal
Painful symptom re-emergence is very common for patients with cervical dystonia and up until now physicians have not been able to fully address this issue with existing treatment options,’ said
The
INDICATION
DAXXIFY (daxibotulinumtoxinA-lanm) for injection is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.
WARNING: DISTANT SPREAD OF TOXIN EFFECT
The effects of DAXXIFY and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. DAXXIFY is not approved for the treatment of spasticity or any conditions other than glabellar lines.
IMPORTANT SAFETY INFORMATION
Contraindications
DAXXIFY contraindications include hypersensitivity to any botulinum toxin preparation or any of the components in the formulation and infection at the injection site(s).
Warnings and Precautions
Please refer to Boxed Warning for Distant Spread of Toxin Effect.
The potency units of DAXXIFY are not interchangeable with other preparations of other botulinum toxin products. Recommended dose and frequency of administration should not be exceeded. Patients should seek immediate medical attention if respiratory, speech or swallowing difficulties occur. Use caution when administering to patients with pre-existing cardiovascular disease. Concomitant neuromuscular disorders may exacerbate clinical effects of treatment.
Adverse Reactions
The most commonly observed adverse reactions (1%) were headache (6%), eyelid ptosis (2%) and facial paresis (1%).
Drug Interactions
Co-administration of DAXXIFY and aminoglycoside antibiotics, anticholinergic agents or any other agents interfering with neuromuscular transmission or muscle relaxants should only be performed with caution as the effect of DAXXIFY may be potentiated. The effect of administering different botulinum neurotoxins during course of treatment with DAXXIFY is unknown.
Use in Specific Populations
DAXXIFY is not recommended for use in children or pregnant women.
About DAXXIFY
DAXXIFY (DaxibotulinumtoxinA-lanm) for injection is the first and only FDA approved long-lasting peptide-formulated neuromodulator product for use in adults for the temporary improvement of moderate to severe frown lines (glabellar lines). 4-5,10-14 DAXXIFY has the ability to deliver year-long results for patients with potentially only two treatments per year and has been proven to be effective, and generally safe and well tolerated.5-8 DAXXIFY is powered by a cell-penetrating peptide technology (Peptide Exchange Technology), Revance’s proprietary, synthetic, 35-amino-acid stabilizing excipient with a highly positive charge, and is free of human serum albumin or animal-based components. 4,5,14 Manufactured exclusively in the
Revance has evaluated this neuromodulator formulation in other Phase 2 clinical studies in aesthetics, including the full upper face, forehead lines and crow’s feet as well as in therapeutic indications, including cervical dystonia and upper limb spasticity. Learn more at RevanceAesthetics.com.
About Cervical Dystonia
According to the
First-line treatment for cervical dystonia is usually neuromodulator (botulinum toxin) injections, but additional treatments can include oral medications, surgery, and complementary therapies. Neuromodulators block the communication between the nerve and the muscle, relaxing the muscle, which alleviates abnormal involuntary movements and postures. Current neuromodulator treatments for cervical dystonia have a duration of effect of approximately three months. Cervical dystonia can occur at any age, although most individuals first experience symptoms in middle age. The condition affects a few hundred thousand adults and children in
About Revance
Revance is a biotechnology company setting the new standard in healthcare with innovative aesthetic and therapeutic offerings that elevate patient and physician experiences. Revance’s aesthetics portfolio of expertly created products and services, including DAXXIFY (DaxibotulinumtoxinA-lanm) for injection, the RHA Collection of dermal fillers, and OPUL, the first-of-its-kind Relational Commerce platform for aesthetic practices, deliver a differentiated and exclusive offering for the company’s elite practice partners and their consumers. Revance has also partnered with
Revance is headquartered in
Resilient Hyaluronic Acid and RHA are trademarks of
BOTOX is a registered trademark of
Forward-Looking Statements
Any statements in this press release that are not statements of historical fact, including statements related to our PDUFA date; our market opportunity; the potential benefits, safety, efficacy and duration of DAXXIFY; the potential to set a new standard of care; development of a biosimilar to BOTOX with our partner,
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate, but are not limited to: our ability to successfully commercialize DAXXIFY and to continue to successfully commercialize the RHA Collection of dermal fillers and OPUL; the results, timing, costs, and completion of our research and development activities and regulatory approvals; our ability to obtain funding for our operations; the timing of capital expenditures; the accuracy of our estimates regarding future expenses, revenues and capital requirements, our financial performance and the economics of DAXXIFY, the RHA Collection of dermal fillers and OPUL; the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, end user demand for our products and services, the aesthetics market, commercialization efforts, business operations, regulatory meetings, inspections and approvals, clinical trials and other aspects of our business and on the market; our ability and the ability of our partners to manufacture supplies for DAXXIFY and our product candidates and to acquire supplies of the RHA Collection of dermal fillers; the uncertain clinical development process; the risk that clinical trials may not have an effective design or generate positive results or that positive results would assure regulatory approval or commercial success; the applicability of clinical study results to actual outcomes; the rate and degree of economic benefit, safety, efficacy, commercial acceptance, market, competition and/or size and growth potential of DAXXIFY, the RHA Collection of dermal fillers, OPUL and our drug product candidates, if approved; reports of adverse events or safety concerns involving DAXXIFY or the RHA Collection of dermal fillers; the timing and cost of commercialization activities; the proper training and administration of our products by physicians and medical staff; our ability to expand sales and marketing capabilities; the status of commercial collaborations; changes in and failures to comply with privacy and data protection laws; our ability to effectively manage our expanded operations in connection with the acquisition of
Contact:
Tel: 949-887-4476
Email: sfahy@revance.com
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