Skip to main content

Revance recently announced it has completed enrollment in a Phase 2 study of plantar fasciitis, a common and painful musculoskeletal condition.

In mid-2017 the company completed a Phase 2 clinical trial for cervical dystonia, a very painful and debilitating neurologic disorder. Based on the Phase 2 safety and efficacy results, along with guidance from the FDA and EMA, Revance plans to proceed to a Phase 3 program in cervical dystonia.

Revance Clinical Program Update:

  • In 2016, Revance initiated a Phase 2 study for treatment of plantar fasciitis (PF). PF is a novel indication and a clinical differentiator from current neuromodulators on the market.
  • Revance completed a Phase 2 clinical study of RT002 for treatment of cervical dystonia in mid-2017. All cohorts in the Phase 2 trial achieved median duration of at least 24 weeks, and patients demonstrated clinical improvement beginning at Week 2 that was sustained through the 24-week study period. In November of 2017, Revance was granted Orphan Drug Designation for RT002 in treating cervical dystonia and plans to initiate its Phase 3 program in 2018.

For the latest information regarding our clinical development programs, please see our public filings with the Securities and Exchange Commissions, as well as the press releases we issue, or visit www.clinicaltrials.gov

Market Facts, Figures & Trends:

  • Use of botulinum toxin products for aesthetic and therapeutic indications represents an estimated $3.4 billion market globally.
  • Therapeutic indications for botulinum toxin represent more than half of the global neuromodulator market. These indications include cervical dystonia, upper and lower limb spasticity, chronic migraine, hyperhidrosis, urinary incontinence, overactive bladder and a number of neurological movement disorders.
  • There are more than 100 therapeutic uses of botulinum toxin that are currently reimbursed by healthcare providers.*

* Reimbursement market research data on file at Revance.

Cervical Dystonia

Cervical Dystonia is an extremely painful, chronic neurological movement disorder where the neck and shoulder muscles contract involuntarily and contort, causing the head to twist or turn to the left, right, upwards, and/or downwards.

Cervical dystonia (also known as Spasmodic Torticollis) affects a person’s ability to control muscle activity, and is often attributed to nervous system damage caused by a stroke, disease or trauma. A rare disorder that can occur at any age, even during infancy, cervical dystonia most often occurs in middle-aged individuals, and is more prevalent in women than men. Those with a family history of cervical dystonia or some other type of dystonia are at higher risk of developing the disorder.

Symptoms generally begin gradually and then reach a plateau where the symptoms don’t get substantially worse.

Unfortunately, there is no cure for cervical dystonia and the condition greatly impacts an individual’s quality of life. In some cases, the disorder resolves without treatment, but sustained remissions are fairly uncommon.

The most commonly prescribed treatment for cervical dystonia is the use of botulinum toxin type A, which can reduce the signs and symptoms.

Facts, Figures & Trends:

  • Muscle movement disorders, including cervical dystonia, comprise about half of the estimated $1.8 billion neuromodulator therapeutic sales, globally.*
  • Cervical dystonia is the third most common movement disorder following essential tremor and Parkinson’s disease.
  • An estimated 3 in every 10,000 people — or about 90,000 people in the US — are known to suffer from cervical dystonia. The number of cases reported in North America is approximately 300,000.
  • Treatment for cervical dystonia involves regular neurological intervention, and a durable response — as preliminarily reported with the investigational agent RT002 injectable — would be desirable.

* Global Industry Analysts, Inc. — Botulinum Toxin — A Strategic Business Report; September 2014.

For more information on cervical dystonia, visit:
https://www.dystonia-foundation.org/what-is-dystonia
http://www.mayoclinic.org/spasmodic-torticollis
https://www.dystonia-foundation.org/understanding-dystonia

Plantar Fasciitis

Plantar Fasciitis (PF) is a subacute, degenerative process that often results in debilitating pain located in the heel and bottom of the foot. The pain experienced is often most severe at the beginning of the day upon onset of physical activity.

Anatomically, the plantar fascia is a thick band of connective tissue that runs the length of the foot from the heel all the way through the arch to the base of the toes. The tissue separates into distinct segments, ultimately dividing into 5 digital bands that connect to the toe joints. In a normal, healthy state, the plantar fascia provides tension to support the foot as well as providing shock absorption during routine as well as more demanding activities like running.

Although the etiology of PF is multifactorial, it is generally believed to result from repeated pressure on the tissue that can create small tears in the fascia or overstretch the fascia. Risk factors for developing PF include foot arch problems, heel spurs, age, heel fat pad atrophy, obesity, weight gain, running activities (e.g. jogging, tennis), weight-bearing occupations, and tight Achilles tendon.

Although plantar fasciitis pain can improve over time, or even resolve itself using conservative treatment methods, progress can nonetheless be slow and frustrating. Furthermore, treatment failure is not uncommon and can lead to considering surgical intervention.

Looking to the future, the introduction of a novel treatment option like botulinum toxin may prove a welcome addition to today’s armamentarium.

Facts, Figures & Trends:

  • An estimated 1 in 10 adults in the U.S. will suffer from plantar fasciitis at some point in their lifetime, with approximately 1 million patient visits per year attributed to PF. 1
  • Plantar fasciitis is the most common cause of heel pain and is responsible for 80% of the cases. 1
  • The incidence and prevalence of PF in women is twice that of men, although the condition is seen in adults of all ages. 2
  • The annual cost of evaluation and treatment for PF is estimated to be more than $250 million dollars. 2

1. Rosenbaum AJ, DiPreta JA, Misener D. Plantar Heel Pain. Med Clin N Am 98. 2014: 339–352 http://dx.doi.org/10.1016/j.mcna.2013.10.009 2. Medscape http://emedicine.medscape.com/article/86143-overview

Hyperhidrosis

Hyperhidrosis is a skin disorder characterized by abnormally increased sweating in excess of that required for thermoregulation (regulation of body temperature).

It can be associated with a significant quality of life burden from a psychological, emotional, occupational, and social perspective. A large number of individuals who suffer from hyperhidrosis consider their condition intolerable. Hyperhidrosis is sometimes referred to as 'the silent handicap'. The number of cases of hyperhidrosis are underreported by patients and underdiagnosed by physicians.

Hyperhidrosis can either be generalized, or localized to specific parts of the body. Hands, feet, armpits, and the groin area are among the most active regions of perspiration due to the high number of sweat glands in these areas.

Use of botulinum toxin type A has been used to block neural control of sweat glands.

Facts, Figures & Trends:

  • An estimated 9 million individuals in the U.S. (approximately 2.8% of the total population) suffer from hyperhidrosis, and more than 50% of those people are not diagnosed or receiving treatment.
  • Currently, axillary hyperhidrosis can be treated with a series of 15 injections of botulinum toxin for each underarm. This painful procedure prohibits the vast majority from seeking treatment.
  • Revance’s topical formulation has been explored as a potential treatment for axillary hyperhidrosis (severe underarm sweating) — a condition well-suited to topical application.

For more information on hyperhidrosis, visit:
International Hyperhidrosis Society: http://www.sweathelp.org/

 

RT002 injectable and topical formulations are investigational product candidates. RT002 is currently undergoing clinical studies for both therapeutic and aesthetic indications.

Presentations & Publications