Min-101 for anhedonia, negative symptoms, and phase III

Medications
1

I asked Minerva if Min-101 was effective for anhedonia, here’s their answer:

"I am responding to your emailed question regarding the impact of treatment with MIN-101 on anhedonia. You will note on the attached presentation of data from the Phase IIb trial with MIN-101 that patients who received the 64 milligram dose of the drug experienced statistically significant improvement in their total anhedonia score (slide #16). Patients who received 32 milligrams also improved but not to a statistically significant degree. This presentation was delivered at the Annual Meeting of the American College of Neuropsychopharmacology (ACNP) last December 2016.

We expect to meet with regulatory authorities in the next several months to discuss the design of our Phase III clinical program with MIN-101 and to initiate the next trial in the second half of this year."

MIN-101 Hot Topics Session 2016 ACNP.pdf (2.4 MB)

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2

Nice! Only 3 more years until Min 101 hits the market.
That is, if it passes phase 3

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3

Viva! Good news!

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4

How long does phase 3 usually take?

5

I read it’s 3 years like you said

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6

I was blessed, my negative symptoms are at low intensity. Unfortunately my cognition seems to be slipping. Hopefully min-101 can deliver when it comes to cognition.

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Per the FDA’s Web site “Phase 3 > Length of Study: 1 to 4 years”

http://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm

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8

lets hope they fast track that baby right into my medicine cabinet

9

Arent they always looking for volunteers to test the meds?

10

i think they usually test on street kids and hobos

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11

Any wonder it takes 3-4 years to get to "us?"
How are they supposed to “test” it if no one wants to volunteer?

12

I would do it but it has to be in your area, its a major inconvenience and it might not even work

13

Not quite. Phase 2 of MIN-101 was performed in Russia and Romania (my country). Unfortunately I didn’t know about it until it was to late to enroll. My pdoc would have referred me, I guess, but my parents probably would’ve been against it.

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14

Here’s to a speedy phase three trial and min being released by 2019

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