- TX-001HR, the main bio-indistinguishable mix treatment of estradiol and progesterone assessed in a randomized, controlled clinical trial met all co-essential adequacy and wellbeing endpoints at different measurements -
- TX-001HR, if endorsed, offers a potential new option for a huge number of post-menopausal ladies as of now utilizing unapproved aggravated hormone treatment for the treatment of VMS -
- Conference call today at 4:30 p.m. ET to examine comes about -
Figure 1. Mean Change from Baseline in Weekly Frequency of Moderate to Severe Hot Flashes for a considerable length of time 1 to 12 (Graphic: Business Wire)
Figure 1. Mean Change from Baseline in Weekly Frequency of Moderate to Severe Hot Flashes for a considerable length of time 1 to 12 (Graphic: Business Wire)
Figure 1. Mean Change from Baseline in Weekly Frequency of Moderate to Severe Hot Flashes for a considerable length of time 1 to 12 (Graphic: Business Wire) Figure 2. Mean Change from Baseline in Weekly Severity of Moderate to Severe Hot Flashes for quite a long time 1 to 12 (Graphic: Business Wire)
December 05, 2016 04:05 PM Eastern Standard Time
BOCA RATON, Fla.- - (BUSINESS WIRE)- - TherapeuticsMD, Inc. (NYSE MKT: TXMD), an inventive ladies' medicinal services organization, today declared positive top-line comes about because of its vital stage 3 Replenish Trial of TX-001HR, an investigational bio-indistinguishable hormone treatment mix of 17ß-estradiol and progesterone in a solitary, oral softgel, for the treatment of direct to serious vasomotor side effects (VMS) because of menopause in post-menopausal ladies with an in place uterus.
"We are extremely satisfied that various measurements of TX-001HR examined in the Replenish Trial showed these positive outcomes, proposing that, if affirmed, this medication item competitor is ready to address the noteworthy interest for bio-indistinguishable hormone treatment"
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The Replenish Trial assessed four measurements of TX-001HR and fake treatment in 1,835 post-menopausal ladies somewhere around 40 and 65 years of age. The dosages considered were:
17ß-estradiol 1 mg/progesterone 100 mg (n = 416)
17ß-estradiol 0.5 mg/progesterone 100 mg (n = 423)
17ß-estradiol 0.5 mg/progesterone 50 mg (n = 421)
17ß-estradiol 0.25 mg/progesterone 50 mg (n = 424)
Fake treatment (n = 151)
The Replenish Trial comes about illustrated:
TX-001HR estradiol 1 mg/progesterone 100 mg and TX-001HR estradiol 0.5 mg/progesterone 100 mg both accomplished each of the four of the co-essential viability endpoints and the essential wellbeing endpoint.
TX-001HR estradiol 1 mg/progesterone 100 mg and TX-001HR estradiol 0.5 mg/progesterone 100 mg both showed a factually noteworthy and clinically significant diminishment from gauge in both the recurrence and seriousness of hot flashes contrasted with fake treatment.
TX-001HR estradiol 0.5 mg/progesterone 50 mg and TX-001HR estradiol 0.25 mg/progesterone 50 mg were not measurably huge at all of the co-essential adequacy endpoints. The estradiol 0.25 mg/progesterone 50 mg dosage was incorporated into the clinical trial as a non-compelling measurements to meet the proposal of the FDA direction to distinguish the most minimal successful measurements.
The rate of agreement endometrial hyperplasia or harm was 0 percent over every one of the four TX-001HR measurements, meeting the proposals set up by the U.S. Sustenance and Drug Agency's (FDA) draft guidance.1
As illustrated in the FDA direction, the co-essential adequacy endpoints in the Replenish Trial were the change from standard in the number and seriousness of hot flashes at weeks 4 and 12 when contrasted with placebo.1 The essential wellbeing endpoint was the occurrence of endometrial hyperplasia with up to 12 months of treatment. General security was likewise assessed.
The consequences of the Replenish Trial (p-estimations of < 0.05 meet FDA direction and bolster confirmation of viability) are outlined in the beneath table and included mixed media.
Recharge Trial Co-Primary Efficacy Endpoints: Mean Change in Frequency and Severity of Hot Flashes Per
Week Versus Placebo at Weeks 4 and 12, VMS-MITT Population
Estradiol/Progesterone 1 mg/100 mg 0.5 mg/100 mg 0.5 mg/50 mg 0.25 mg/50 mg Placebo
(n = 141) (n = 149) (n = 147) (n = 154) (n = 135)
Recurrence
Week 4 P-esteem versus placebo <0.001 0.013 0.141 0.001 -
Week 12 P-esteem versus placebo <0.001 0.002 <0.001 -
Seriousness
Week 4 P-esteem versus placebo 0.031 0.005 0.401 0.100 -
Week 12 P-esteem versus placebo <0.001 0.018 0.096 -
Recharge Trial Primary Safety Endpoint: Incidence of Consensus Endometrial Hyperplasia or Malignancy up to
12 months, Endometrial Safety Population(ŧ)
Endometrial Hyperplasia 0% (0/280) 0% (0/303) 0% (0/306) 0% (0/274) 0% (0/92)
Glove = Modified goal to treat
ŦPer FDA, accord hyperplasia alludes to the simultaneousness of two of the three pathologists be acknowledged as the last diagnosis1
P-esteem < 0.05 meets FDA direction and backings confirmation of adequacy
"We are exceptionally satisfied that various measurements of TX-001HR contemplated in the Replenish Trial showed these positive outcomes, proposing that, if endorsed, this medication item competitor is ready to address the noteworthy interest for bio-indistinguishable hormone treatment," said Chief Executive Officer Robert G. Finizio. "We have effectively propelled the science for post-menopausal ladies' wellbeing by figuring out how to viably join bio-indistinguishable estradiol and bio-indistinguishable progesterone. The requirement for a bio-indistinguishable FDA-endorsed blend treatment has been unanswered for quite a long time, driving ladies to utilize unapproved drugs combined by autonomous and group drug stores that intensify these items. We trust that TX-001HR, if endorsed, will give ladies, human services suppliers and drug specialists with a demonstrated protected, successful and protection repaid bio-indistinguishable mix item, at long last noting that need. We will keep on evaluating these promising information, and anticipate presenting a New Drug Application for TX-001HR to the Food and Drug Administration as ahead of schedule as the second from last quarter of 2017."
The trial additionally showed a measurements reaction supporting the higher dosages of estradiol in mix with progesterone. The accessibility of various dosages of TX-001HR would take into account individualized treatment to address the issues of a different populace of ladies.
The most widely recognized antagonistic occasions (>5 percent) provided details regarding normal in all the dynamic treatment gatherings were migraine, nasopharyngitis, bosom delicacy, and upper respiratory contamination. There was a low reported frequency of unfavorable occasions of lethargy with TX-001HR, rather than economically accessible oral progesterone where sluggishness has been accounted for as a noteworthy reaction. There were no sudden wellbeing signals.
The Replenish Trial assessed different optional endpoints utilizing all around approved patient reported result instruments, including the Menopause-Specific Quality of Life (MENQOL), the Clinical Global Impression scale (CGI), and the responder examination rate. Both TX-001HR estradiol 1 mg/progesterone 100 mg and TX-001HR estradiol 0.5 mg/progesterone 100 mg showed clinically important and measurably noteworthy upgrades in the auxiliary endpoints utilizing these apparatuses.
Extra adequacy and wellbeing investigations of the Replenish Trial information are continuous and TherapeuticsMD arrangements to present the full Replenish Trial comes about for presentation at future logical gatherings and for distribution in companion checked on diaries.
"TX-001HR is the principal bio-indistinguishable blend hormone treatment of estradiol in mix with progesterone to be assessed in a huge, very much controlled, randomized clinical trial," said TherapeuticsMD Chief Medical Officer Sebastian Mirkin, M.D. "The Replenish Trial showed interestingly wellbeing and hearty adequacy for the treatment of hot flashes at various measurements of TX-001HR. On the off chance that endorsed, TX-001HR estradiol 1 mg/progesterone 100 mg and TX-001HR estradiol 0.5 mg/progesterone 100 mg would furnish TherapeuticsMD with an entire portfolio to meet the requests of ladies as of now taking unapproved aggravated hormones for the treatment of VMS, alongside the social insurance suppliers and drug stores that recommend and exacerbate these items."
About TX-001HR
TX-001HR is a novel blend of 17ß-estradiol and characteristic progesterone under scrutiny for treating vasomotor indications identified with menopause. In the event that affirmed by the FDA, TX-001HR would speak to the main bio-indistinguishable estradiol and progesterone endorsed for use in a solitary, joined item for postmenopausal ladies with an in place uterus offering ladies a critical contrasting option to both the accessible FDA-affirmed manufactured (non-bio-indistinguishable) hormones and the unapproved intensified bio-indistinguishable hormone items. Bio-indistinguishable alludes to estradiol and progesterone that are molecularly indistinguishable to the hormones circling actually in the lady's body. An expected one to more than two million ladies in the U.S. are utilizing unapproved, exacerbated bio-indistinguishable hormone treatments to treat vasomotor symptoms.2 Leading medicinal social orders and the FDA prompt that intensified hormone treatments may posture huge hazard to ladies given absence of viability and security information and absence of uniform assembling forms.
TX-001HR was produced utilizing TherapeuticsMD's interesting SYMBODATM innovation (signifying "like the body"), which empowers fractional and finish solubilization of estradiol and progesterone into medium-chain unsaturated fat oils frequently got from coconut oil.
About Menopause and Vasomotor Symptoms (VMS)
Menopause is a characteristic life-organize move for ladies with a normal onset of 51 years. As per the United States Census Bureau, roughly 43 million ladies in the U.S. are of menopausal age (45-64 years).3
As the ovaries quit delivering hormones, levels of coursing estrogen diminish, regularly bringing on vasomotor side effects (VMS, for example, night sweats, hot flashes, and rest unsettling influences. VMS influence upwards of 60-80 percen
- TX-001HR, if endorsed, offers a potential new option for a huge number of post-menopausal ladies as of now utilizing unapproved aggravated hormone treatment for the treatment of VMS -
- Conference call today at 4:30 p.m. ET to examine comes about -
Figure 1. Mean Change from Baseline in Weekly Frequency of Moderate to Severe Hot Flashes for a considerable length of time 1 to 12 (Graphic: Business Wire)
Figure 1. Mean Change from Baseline in Weekly Frequency of Moderate to Severe Hot Flashes for a considerable length of time 1 to 12 (Graphic: Business Wire)
Figure 1. Mean Change from Baseline in Weekly Frequency of Moderate to Severe Hot Flashes for a considerable length of time 1 to 12 (Graphic: Business Wire) Figure 2. Mean Change from Baseline in Weekly Severity of Moderate to Severe Hot Flashes for quite a long time 1 to 12 (Graphic: Business Wire)
December 05, 2016 04:05 PM Eastern Standard Time
BOCA RATON, Fla.- - (BUSINESS WIRE)- - TherapeuticsMD, Inc. (NYSE MKT: TXMD), an inventive ladies' medicinal services organization, today declared positive top-line comes about because of its vital stage 3 Replenish Trial of TX-001HR, an investigational bio-indistinguishable hormone treatment mix of 17ß-estradiol and progesterone in a solitary, oral softgel, for the treatment of direct to serious vasomotor side effects (VMS) because of menopause in post-menopausal ladies with an in place uterus.
"We are extremely satisfied that various measurements of TX-001HR examined in the Replenish Trial showed these positive outcomes, proposing that, if affirmed, this medication item competitor is ready to address the noteworthy interest for bio-indistinguishable hormone treatment"
Tweet this
The Replenish Trial assessed four measurements of TX-001HR and fake treatment in 1,835 post-menopausal ladies somewhere around 40 and 65 years of age. The dosages considered were:
17ß-estradiol 1 mg/progesterone 100 mg (n = 416)
17ß-estradiol 0.5 mg/progesterone 100 mg (n = 423)
17ß-estradiol 0.5 mg/progesterone 50 mg (n = 421)
17ß-estradiol 0.25 mg/progesterone 50 mg (n = 424)
Fake treatment (n = 151)
The Replenish Trial comes about illustrated:
TX-001HR estradiol 1 mg/progesterone 100 mg and TX-001HR estradiol 0.5 mg/progesterone 100 mg both accomplished each of the four of the co-essential viability endpoints and the essential wellbeing endpoint.
TX-001HR estradiol 1 mg/progesterone 100 mg and TX-001HR estradiol 0.5 mg/progesterone 100 mg both showed a factually noteworthy and clinically significant diminishment from gauge in both the recurrence and seriousness of hot flashes contrasted with fake treatment.
TX-001HR estradiol 0.5 mg/progesterone 50 mg and TX-001HR estradiol 0.25 mg/progesterone 50 mg were not measurably huge at all of the co-essential adequacy endpoints. The estradiol 0.25 mg/progesterone 50 mg dosage was incorporated into the clinical trial as a non-compelling measurements to meet the proposal of the FDA direction to distinguish the most minimal successful measurements.
The rate of agreement endometrial hyperplasia or harm was 0 percent over every one of the four TX-001HR measurements, meeting the proposals set up by the U.S. Sustenance and Drug Agency's (FDA) draft guidance.1
As illustrated in the FDA direction, the co-essential adequacy endpoints in the Replenish Trial were the change from standard in the number and seriousness of hot flashes at weeks 4 and 12 when contrasted with placebo.1 The essential wellbeing endpoint was the occurrence of endometrial hyperplasia with up to 12 months of treatment. General security was likewise assessed.
The consequences of the Replenish Trial (p-estimations of < 0.05 meet FDA direction and bolster confirmation of viability) are outlined in the beneath table and included mixed media.
Recharge Trial Co-Primary Efficacy Endpoints: Mean Change in Frequency and Severity of Hot Flashes Per
Week Versus Placebo at Weeks 4 and 12, VMS-MITT Population
Estradiol/Progesterone 1 mg/100 mg 0.5 mg/100 mg 0.5 mg/50 mg 0.25 mg/50 mg Placebo
(n = 141) (n = 149) (n = 147) (n = 154) (n = 135)
Recurrence
Week 4 P-esteem versus placebo <0.001 0.013 0.141 0.001 -
Week 12 P-esteem versus placebo <0.001 0.002 <0.001 -
Seriousness
Week 4 P-esteem versus placebo 0.031 0.005 0.401 0.100 -
Week 12 P-esteem versus placebo <0.001 0.018 0.096 -
Recharge Trial Primary Safety Endpoint: Incidence of Consensus Endometrial Hyperplasia or Malignancy up to
12 months, Endometrial Safety Population(ŧ)
Endometrial Hyperplasia 0% (0/280) 0% (0/303) 0% (0/306) 0% (0/274) 0% (0/92)
Glove = Modified goal to treat
ŦPer FDA, accord hyperplasia alludes to the simultaneousness of two of the three pathologists be acknowledged as the last diagnosis1
P-esteem < 0.05 meets FDA direction and backings confirmation of adequacy
"We are exceptionally satisfied that various measurements of TX-001HR contemplated in the Replenish Trial showed these positive outcomes, proposing that, if endorsed, this medication item competitor is ready to address the noteworthy interest for bio-indistinguishable hormone treatment," said Chief Executive Officer Robert G. Finizio. "We have effectively propelled the science for post-menopausal ladies' wellbeing by figuring out how to viably join bio-indistinguishable estradiol and bio-indistinguishable progesterone. The requirement for a bio-indistinguishable FDA-endorsed blend treatment has been unanswered for quite a long time, driving ladies to utilize unapproved drugs combined by autonomous and group drug stores that intensify these items. We trust that TX-001HR, if endorsed, will give ladies, human services suppliers and drug specialists with a demonstrated protected, successful and protection repaid bio-indistinguishable mix item, at long last noting that need. We will keep on evaluating these promising information, and anticipate presenting a New Drug Application for TX-001HR to the Food and Drug Administration as ahead of schedule as the second from last quarter of 2017."
The trial additionally showed a measurements reaction supporting the higher dosages of estradiol in mix with progesterone. The accessibility of various dosages of TX-001HR would take into account individualized treatment to address the issues of a different populace of ladies.
The most widely recognized antagonistic occasions (>5 percent) provided details regarding normal in all the dynamic treatment gatherings were migraine, nasopharyngitis, bosom delicacy, and upper respiratory contamination. There was a low reported frequency of unfavorable occasions of lethargy with TX-001HR, rather than economically accessible oral progesterone where sluggishness has been accounted for as a noteworthy reaction. There were no sudden wellbeing signals.
The Replenish Trial assessed different optional endpoints utilizing all around approved patient reported result instruments, including the Menopause-Specific Quality of Life (MENQOL), the Clinical Global Impression scale (CGI), and the responder examination rate. Both TX-001HR estradiol 1 mg/progesterone 100 mg and TX-001HR estradiol 0.5 mg/progesterone 100 mg showed clinically important and measurably noteworthy upgrades in the auxiliary endpoints utilizing these apparatuses.
Extra adequacy and wellbeing investigations of the Replenish Trial information are continuous and TherapeuticsMD arrangements to present the full Replenish Trial comes about for presentation at future logical gatherings and for distribution in companion checked on diaries.
"TX-001HR is the principal bio-indistinguishable blend hormone treatment of estradiol in mix with progesterone to be assessed in a huge, very much controlled, randomized clinical trial," said TherapeuticsMD Chief Medical Officer Sebastian Mirkin, M.D. "The Replenish Trial showed interestingly wellbeing and hearty adequacy for the treatment of hot flashes at various measurements of TX-001HR. On the off chance that endorsed, TX-001HR estradiol 1 mg/progesterone 100 mg and TX-001HR estradiol 0.5 mg/progesterone 100 mg would furnish TherapeuticsMD with an entire portfolio to meet the requests of ladies as of now taking unapproved aggravated hormones for the treatment of VMS, alongside the social insurance suppliers and drug stores that recommend and exacerbate these items."
About TX-001HR
TX-001HR is a novel blend of 17ß-estradiol and characteristic progesterone under scrutiny for treating vasomotor indications identified with menopause. In the event that affirmed by the FDA, TX-001HR would speak to the main bio-indistinguishable estradiol and progesterone endorsed for use in a solitary, joined item for postmenopausal ladies with an in place uterus offering ladies a critical contrasting option to both the accessible FDA-affirmed manufactured (non-bio-indistinguishable) hormones and the unapproved intensified bio-indistinguishable hormone items. Bio-indistinguishable alludes to estradiol and progesterone that are molecularly indistinguishable to the hormones circling actually in the lady's body. An expected one to more than two million ladies in the U.S. are utilizing unapproved, exacerbated bio-indistinguishable hormone treatments to treat vasomotor symptoms.2 Leading medicinal social orders and the FDA prompt that intensified hormone treatments may posture huge hazard to ladies given absence of viability and security information and absence of uniform assembling forms.
TX-001HR was produced utilizing TherapeuticsMD's interesting SYMBODATM innovation (signifying "like the body"), which empowers fractional and finish solubilization of estradiol and progesterone into medium-chain unsaturated fat oils frequently got from coconut oil.
About Menopause and Vasomotor Symptoms (VMS)
Menopause is a characteristic life-organize move for ladies with a normal onset of 51 years. As per the United States Census Bureau, roughly 43 million ladies in the U.S. are of menopausal age (45-64 years).3
As the ovaries quit delivering hormones, levels of coursing estrogen diminish, regularly bringing on vasomotor side effects (VMS, for example, night sweats, hot flashes, and rest unsettling influences. VMS influence upwards of 60-80 percen
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