https://en.wikipedia.org/wiki/Ecopipam
https://www.biospace.com/article/releases/emalex-biosciences-receives-fda-fast-track-designation-for-ecopipam-for-the-treatment-of-patients-wi th-tourette-syndrome/
Ecopipam är alltså en dopamin antagonist som det forskas på för behandling av tics, tourettes syndrom, stamning mm. Vad jag har kunnat läsa mig till så verkar man har forskat på det sen iaf 2016 och enligt länken ovan fick man s.k Fast Track för FDA godkännande 2019.
Vad innebär det att man har s.k Fast Track hos FDA och hur långt in i framtiden tror ni det dröjer innan Ecopipam finns på marknaden? Hur mycket ytterligare tid brukar det ta innan det blir godkänt på den svenska marknaden efter det blir godkänt i USA?
Känner ni till något ytterligare om denna substans?
Edit:
Hittade att där var en pågående studie fas 2 studie som avslutas i oktober.
https://clinicaltrials.gov/ct2/show/NCT04007991
Citat:
Ecopipam (development codes SCH-39166, EBS-101, and PSYRX-101) is an experimental drug that acts as a selective dopamine D1/D5 receptor antagonist, with little affinity for either dopamine D2-like or 5-HT2 receptors.[1]
...
As of 2021, Emalex Bioscineces is investigating its potential use for central nervous system disorders.[9] Open-label studies have found ecopipam to reduce gambling behaviors in subjects with pathological gambling[10] and to decrease the motor and vocal tics in adults with Tourette syndrome.[11] A subsequent double-blind placebo-controlled study in pediatric subjects confirmed ecopipam's ability to ameliorate the motor and vocal symptoms seen in patients with Tourette's syndrome.[12] Ecopipam is currently in a phase 2/3 clinical trial for the treatment of Tourette's syndrome in children ages 7 to 17.[13]
Ecopipam is additionally under development for the treatment of Lesch–Nyhan syndrome (phase 3) and restless legs syndrome (phase 1/2).[14]
Ecopipam is an investigational first-in-class drug being evaluated for the treatment of childhood-onset fluency disorder (stuttering) in adults. It is under development for the treatment of stuttering (phase 2) [15]
...
As of 2021, Emalex Bioscineces is investigating its potential use for central nervous system disorders.[9] Open-label studies have found ecopipam to reduce gambling behaviors in subjects with pathological gambling[10] and to decrease the motor and vocal tics in adults with Tourette syndrome.[11] A subsequent double-blind placebo-controlled study in pediatric subjects confirmed ecopipam's ability to ameliorate the motor and vocal symptoms seen in patients with Tourette's syndrome.[12] Ecopipam is currently in a phase 2/3 clinical trial for the treatment of Tourette's syndrome in children ages 7 to 17.[13]
Ecopipam is additionally under development for the treatment of Lesch–Nyhan syndrome (phase 3) and restless legs syndrome (phase 1/2).[14]
Ecopipam is an investigational first-in-class drug being evaluated for the treatment of childhood-onset fluency disorder (stuttering) in adults. It is under development for the treatment of stuttering (phase 2) [15]
https://www.biospace.com/article/releases/emalex-biosciences-receives-fda-fast-track-designation-for-ecopipam-for-the-treatment-of-patients-wi th-tourette-syndrome/
Citat:
Emalex Biosciences Receives FDA Fast Track Designation for Ecopipam for the Treatment of Patients with Tourette Syndrome
Ecopipam är alltså en dopamin antagonist som det forskas på för behandling av tics, tourettes syndrom, stamning mm. Vad jag har kunnat läsa mig till så verkar man har forskat på det sen iaf 2016 och enligt länken ovan fick man s.k Fast Track för FDA godkännande 2019.
Vad innebär det att man har s.k Fast Track hos FDA och hur långt in i framtiden tror ni det dröjer innan Ecopipam finns på marknaden? Hur mycket ytterligare tid brukar det ta innan det blir godkänt på den svenska marknaden efter det blir godkänt i USA?
Känner ni till något ytterligare om denna substans?
Edit:
Hittade att där var en pågående studie fas 2 studie som avslutas i oktober.
https://clinicaltrials.gov/ct2/show/NCT04007991
__________________
Senast redigerad av Dogmatix 2021-08-08 kl. 23:49.
Senast redigerad av Dogmatix 2021-08-08 kl. 23:49.