Knight Therapeutics Inc., (TSX: GUD) ("Knight"), a pan-American
(ex-USA) specialty pharmaceutical company, announced today the
launch of IMVEXXY® in Canada. IMVEXXY® (estradiol vaginal inserts)
is approved for the treatment of postmenopausal moderate to severe
dyspareunia, a symptom of vulvar and vaginal atrophy (VVA). VVA is
a prevalent, chronic, and progressive condition associated with
menopause. Common symptoms of VVA include dryness, discomfort, and
pain in the vaginal and vulvar areas1-4. IMVEXXY® is the only
product in its therapeutic class to offer a 4 mcg and 10 mcg dose
of 17β estradiol; the 4 mcg represents the lowest effective Health
Canada-approved dose of vaginal estradiol.
Dr. Vivien Brown, a family physician known to
advocate on a national and international scale on women’s health
issues, preventative healthcare, and healthy aging commented “There
is a need to raise awareness amongst patients about the challenges
of menopause, in particular the most bothersome symptoms such as
painful intercourse. The launch of IMVEXXY® provides a safe,
simple, easy to use and effective treatment to add to our
armamentarium.
“We are very excited about the launch of
IMVEXXY®, a new treatment option for postmenopausal women in
Canada. IMVEXXY® offers women a simple, effective alternative that
is reimbursed across Canada and will address the very bothersome
and painful VVA symptoms that significantly impacts quality of
life,” said Samira Sakhia, President and Chief Executive Officer of
Knight.
Knight and TherapeuticsMD signed a license
agreement in July 2018 pursuant to which TherapeuticsMD granted
Knight the exclusive Canadian commercialization rights to IMVEXXY®
(estradiol vaginal inserts). Under the terms of the license
agreement related to IMVEXXY® in Canada, Knight will pay
TherapeuticsMD sales milestone fees and royalties based upon
certain aggregate annual sales of IMVEXXY® in Canada.
About
IMVEXXY®
IMVEXXY® (estradiol vaginal inserts) was
developed for the treatment of postmenopausal moderate to severe
dyspareunia, a symptom of vulvar and vaginal atrophy (VVA).
IMVEXXY® is a small, light pink, tear-shaped,
softgel vaginal insert that is digitally inserted into the vagina.
IMVEXXY® inserts contain 4 mcg or 10mcg of estradiol and is
administered initially intravaginally once daily at approximately
the same time for two weeks, followed by one insert twice weekly,
every three to four days.
IMVEXXY® was designed for easy insertion at any
time of day and with no need for an applicator. The goal of
IMVEXXY® is to provide an early onset of efficacy, with low
systemic estrogen levels and improved administration to enhance
treatment compliance and patient satisfaction.
About VVA
VVA is a chronic and progressive medical
condition that can have a deleterious effect on quality of life
(QOL), significantly increase risk for depression and anxiety5,
interfere with sexual function and lead to loss of intimacy with
partners6. Up to 84% of postmenopausal women report symptoms
associated with VVA and approximately half of women report their
symptoms to be moderate or severe7-14. However, VVA is severely
undertreated with only 7% of women who receive a prescription
treatment15.
Common symptoms of VVA include dyspareunia,
vaginal dryness, irritation, burning sensation, dysuria, and
vaginal discharge1,2,16. Dyspareunia and vaginal dryness are
closely linked and are the most commonly reported symptoms by women
with VVA due to menopause, and can either occur early during the
menopause transition or after several years of reduced estrogen
levels17. Unlike vasomotor symptoms (VMS) associated with
menopause, VVA symptoms are progressive and do not subside or
resolve with time2.
Results of multiple surveys show that VVA
symptoms can have a negative impact on sex life,
marriage/relationship, self-esteem, and social life6,9,10,15. For
most women, pain during intercourse can be a factor in loss of
libido and arousal and can affect their relationship with their
partner 20. VVA symptoms can have a psychological impact on sexual
activities, with 52% to 80% of women (nationally and
internationally) believing that vaginal discomfort would have a
negative impact on their QOL and 40% to 68% believing that VVA
would decrease satisfaction, frequency, and spontaneity of
sex10,15,16.
For the treatment of VVA, most women (55%) chose
the treatment that was recommended by their HCP, 25% chose a method
based on how it was administered, and only 5% chose it based on
recommendation of a friend or family member. A small percentage of
women (7%) were using prescribed VVA therapies, 25% were using OTC
therapies, 18% were past users of a prescribed therapy, and 50% had
never used a treatment. Before talking to an HCP, only about
one-third of the women were extremely or very familiar with VVA
treatment options (oral hormone therapies (HT), vaginal ET, OTC
products, and lifestyle changes)7.
Please see the Full
IMVEXXY® Canadian Product
Monograph available
at https://knighttx.com/CA/products/.
About Knight Therapeutics
Inc.
Knight Therapeutics Inc., headquartered in
Montreal, Canada, is a specialty pharmaceutical company focused on
acquiring or in-licensing and commercializing pharmaceutical
products for Canada and Latin America. Knight's Latin American
subsidiaries operate under United Medical, Biotoscana Farma and
Laboratorio LKM. Knight Therapeutics Inc.'s shares trade on TSX
under the symbol GUD. For more information about Knight
Therapeutics Inc., please visit the company's web site at
www.knighttx.com or www.sedarplus.com.
Forward-Looking Statements for Knight
Therapeutics Inc.
This document may contain forward-looking
statements for Knight Therapeutics Inc. and its subsidiaries. These
forward-looking statements, by their nature, necessarily involve
risks and uncertainties that could cause actual results to differ
materially from those contemplated by the forward-looking
statements. Knight Therapeutics Inc. considers the assumptions on
which these forward-looking statements are based to be reasonable
at the time they were prepared but cautions the reader that these
assumptions regarding future events, many of which are beyond the
control of Knight Therapeutics Inc. and its subsidiaries, may
ultimately prove to be incorrect. Factors and risks, which could
cause actual results to differ materially from current expectations
are discussed in Knight Therapeutics Inc.'s Annual Report and in
Knight Therapeutics Inc.'s Annual Information Form for the year
ended December 31, 2022 as filed on www.sedarplus.com. Knight
Therapeutics Inc. disclaims any intention or obligation to update
or revise any forward-looking statements whether because of new
information or future events, except as required by law.
References:
- Mac Bride MB,
Rhodes DJ, Shuster LT. Vulvovaginal atrophy. Mayo Clin
Proc. 2010;85(1):87-94.
- The North
American Menopause Society. Management of symptomatic vulvovaginal
atrophy: 2013 position statement of The North American Menopause
Society. Menopause. 2013;20(9):888-902.
- Wysocki S,
Kingsberg S, Krychman M. Management of vaginal atrophy:
implications from the REVIVE survey. Clin MedInsights Reprod
Health. 2014;8:23-30.
- Chen L, Ng M,
van der Vlugt TH, Price PH, Orencia A. Statistical considerations
for the efficacy assessment of clinical studies of vulvar and
vaginal atrophy. Ther Innov Regul
Sci. 2010;44(5):581-588.
- Moyneur E, Dea K, Derogatis LR,
Vekeman F, Dury AY, Labrie F. Prevalence of depression and anxiety
in women newly diagnosed with vulvovaginal atrophy and dyspareunia.
Menopause. 2020;27(2):134-142.
- Kingsberg SA, Wysocki S, Magnus L,
Krychman ML. Vulvar and vaginal atrophy in postmenopausal women:
findings from the REVIVE (REal Women's VIews of Treatment Options
for Menopausal Vaginal ChangEs) survey. J Sex Med.
2013;10(7):1790-1799.
- Kingsberg SA, Krychman M, Graham S,
Bernick B, Mirkin S. The Women's EMPOWER Survey: Identifying
Women's Perceptions on Vulvar and Vaginal Atrophy and Its
Treatment. J Sex Med. 2017;14(3):413-424.
- Krychman M, Kingsberg S. REVEAL:
Revealing Vaginal Effects at Mid-Life: surveys of postmenopausal
women and health care professionals who treat postmenopausal women.
Wyeth; 2009.
- Nappi RE, Kokot-Kierepa M. Vaginal
Health: Insights, Views & Attitudes (VIVA) - results from an
international survey. Climacteric. 2012;15(1):36-44.
- Nappi RE, Kokot-Kierepa M. Women's
voices in the menopause: results from an international survey on
vaginal atrophy. Maturitas. 2010;67(3):233-238.
- Nappi RE, Mattsson L, Lachowsky M,
Maamari R, Giraldi A. The CLOSER survey: impact of postmenopausal
vaginal discomfort on relationships between women and their
partners in Northern and Southern Europe. Maturitas.
2013;75(4):373-379.
- Palma F, Volpe A, Villa P, Cagnacci
A. Vaginal atrophy of women in postmenopause. Results from a
multicentric observational study: The AGATA study. Maturitas.
2016;83:40-44.
- Santoro N, Komi J. Prevalence and
impact of vaginal symptoms among postmenopausal women. J Sex Med.
2009;6(8):2133-2142.
- Simon JA, Kokot-Kierepa M,
Goldstein J, Nappi RE. Vaginal health in the United States: results
from the Vaginal Health: Insights, Views & Attitudes survey.
Menopause. 2013;20(10):1043-1048.
- Krychman M, Graham S, Bernick B,
Mirkin S, Kingsberg SA. The Women's EMPOWER Survey: Women's
Knowledge and Awareness of Treatment Options for Vulvar and Vaginal
Atrophy Remains Inadequate. J Sex Med. 2017;14(3):425-433.
- Parish SJ, Nappi RE, Krychman ML,
et al. Impact of vulvovaginal health on postmenopausal women: a
review of surveys on symptoms of vulvovaginal atrophy. Int J Womens
Health. 2013;5:437-447.
- NAMS. Changes in the Vagina and
Vulva. 2017;
http://www.menopause.org/for-women/sexual-health-menopause-online/changes-at-midlife/changes-in-the-vagina-and-vulva.
Accessed April 3, 2017.
CONTACT INFORMATION:
Knight Therapeutics Inc. |
|
|
|
Samira Sakhia |
Arvind Utchanah |
President & Chief Executive Officer |
Chief Financial Officer |
T: 514.484.4483 |
T. +598.2626.2344 |
F: 514.481.4116 |
|
Email: IR@knighttx.com |
Email: IR@knighttx.com |
Website: www.knighttx.com |
Website: www.knighttx.com |
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