Schizophrenia

[midastouch017]

Allergan and Richter win FDA approval for a once-rejected schizophrenia pill
By Damian Garde

Gedeon Richter's Erik Bogsch
Partners Allergan ($AGN) and Gedeon Richter convinced a once-skeptical FDA to clear the antipsychotic drug cariprazine on a second pass, winning approval to treat schizophrenia and bipolar disorder.
The agency rejected cariprazine in 2013 and demanded more clinical trial data to determine the ideal dose of the drug, its inventors said at the time. Two years later, Allergan and Gedeon completed a follow-up Phase III trial in which cariprazine met its goals of reducing schizophrenic relapses compared with placebo, adding those results to combined data from more than 2,700 schizophrenia and bipolar patients in their successful resubmission.
Cariprazine, to be sold as Vraylar, was once considered a potential blockbuster, with Richter setting its sales potential at as much as $2 billion a year. But the drug's long path to market has dampened enthusiasm among analysts, and Evercore-ISI's Umer Raffat pegs its peak value closer to $200 million a year.
Despite the delay, cariprazine's approval "is a notable achievement for Gedeon Richter's discovery platform," Managing Director Erik Bogsch said in a statement. "Despite the variety of treatments available for the millions living with bipolar I disorder and schizophrenia, unmet needs remain and we are proud to offer an additional option to help patients manage their symptoms."
Cariprazine came into Allergan's possession through a long string of biopharma deals. In 2004, Richter licensed the drug to Forest Laboratories only to see that company acquired by Actavis for $25 billion in 2014. Earlier this year, Actavis closed its $66 billion deal to buy Allergan and adopted its name, cementing cariprazine's final commercial home.

FDA approves new drug to treat schizophrenia and bipolar disorder

The U.S. Food and Drug Administration today approved Vraylar (cariprazine) capsules to treat schizophrenia and bipolar disorder in adults.

"Schizophrenia and bipolar disorder can be disabling and can greatly interfere with day-to-day activities," said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. "It is important to have a variety of treatment options available to patients with mental illnesses so that treatment plans can be tailored to meet a patient's individual needs."

Schizophrenia is a chronic, severe and disabling brain disorder affecting about one percent of Americans. Typically, symptoms are first seen in adults younger than 30 years of age and include hearing voices or seeing things that are not there, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn.

Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks. The symptoms of bipolar disorder include alternating periods of depression and high, irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior and a decreased need for sleep.

The efficacy of Vraylar in treating schizophrenia was demonstrated in 1,754 participants in three six-week clinical trials. In each of the trials, Vraylar was shown to reduce the symptoms of schizophrenia compared to placebo.

The efficacy of Vraylar in treating bipolar disorder was shown in three three-week clinical trials of 1,037 participants. Vraylar was shown to reduce symptoms of bipolar disorder in each of the trials.

Vraylar and all other FDA-approved drugs used to treat schizophrenia and bipolar disorder have a Boxed Warning alerting health care professionals about an increased risk of death associated with the use of these drugs in older people with dementia-related psychosis. Neither Vraylar nor any other drug in this class is approved to treat such patients.

The most common side effects reported by participants receiving Vraylar in the clinical trials for schizophrenia were extrapyramidal symptoms, such as tremor, slurred speech, and involuntary muscle movements. The most common side effects reported by trial participants receiving Vraylar for bipolar disorder were extrapyramidal symptoms, the urge to move (akathisia), indigestion (dyspepsia), vomiting, drowsiness (somnolence) and restlessness.

Vraylar is manufactured by Forest Laboratories LLC of Jersey City, New Jersey and distributed by Actavis Pharma Inc. of Parsippany, New Jersey.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

[mnfats]

I finally got it right on the 17th try. lol

[midastouch017]

One of the rare times i enjoyed missing......

[mnfats]

Check this out.

http://www.gjk2.com/test/test.swf

[midastouch017]

So you're Greek? You don't sound Greek to me LOL

[mnfats]

I'm with you. Believe me, I've heard enough of the behind the Greek jokes to last more than a lifetime. LOL They really don't bother me at all. Now if you can tell something wasn't meant in jest, that's a different story.

[midastouch017]

Nobody's perfect ..... meaning i enjoy non PC
jokes even when directed against my religion,
my beliefs, whatever however over there some
readers are ultra sensitive

[mnfats]

They must be very Politically Correct. Not sure I like that.

[midastouch017]

i wouldn't dare post it on TMF HURL board, it would
get pulled off in two secs, maybe one!

[mnfats]

Shame on your daughter. lol

[midastouch017]

My daughter just walked into the living room and said, "Dad cancel my allowance, rent my room out, throw all my clothes out of the window, take my TV, stereo, iPhone and jewelry to the charity shop. Sell my car, take my front door key and throw me out of the house.”

Well she didn't actually put it quite like that.

What she said was, "Dad, this is my new boyfriend, Mohammad."

[mnfats]

Thanks, I'll give it a go.

[midastouch017]

At your leisure fats.... no rush,
better yet, no strings attached.
Take care

[mnfats]

I'll check it out tomorrow. Have to leave here shortly.

Thanks

[midastouch017]

I have sent you an 'Invite a Friend to Post' to your
email. Welcome to join and be able to post there too.

[mnfats]

I think I'll bookmark it.

[midastouch017]

You read at most 14 reaction posts on that specific thread
not 70 (which is the # of recs the post rcvd)....
Anyway, in general i like this TMF HURL (humor and urban
legend) board. Some funny stuff there.

[mnfats]

I did read the replies to the joke. Reason for my post. Are you referring to the other topics?

[midastouch017]

No, 70 people liked (= recommended) the joke,
14 reacted to it. Read the thread, some are
indeed strange

[mnfats]

Man, do you hang out with some strange dudes. LOL

70 replies???????????????????????

[midastouch017]

I posted it here, lookit the recs it got, but most
importantly the various reactions it got.

http://boards.fool.com/programmers-logic-29174279.aspx?sort=whole#29174279

Seems to me you are a programmer to

[mnfats]

I would have done the same thing. Where's the joke? LOL

[midastouch017]

A wife asks her husband, a programmer;
"Could you please go shopping for me and buy one
carton of milk, and if they have eggs, get 6!"
A short time later the husband comes back with 6
cartons of milk.
The wife asks him, "Why the hell did you buy 6
cartons of milk?"


He replied, "They had eggs."

[mnfats]

Another classic?????????

Rabbi Levy is addressing the 'Enlighten Your Daughter' meeting of the synagogue women's guild. "Ladies," he says, "I'm sure some of you know by now that the unfortunate Jonathan Bloom has been sent to prison for making love to his wife Sadie's dead body." A number of 'Oy Vays' are heard from the ladies present. "You might also be interested to know," the Rabbi goes on to say, "that I spoke to Jonathan yesterday and I now firmly believe that his actions were entirely innocent and accidental. So although we are all feeling sorry for Jonathan, there is a lesson to be learned. Ladies, go back home to your daughters and tell them that when making love with a good Jewish husband, they should please make a little wiggle."

[midastouch017]

welcome anytime, fats

[mnfats]

I should spend some time there so I would know things like that. lol

[midastouch017]

not old, classic

[mnfats]

I guess my joke is pretty old one over there. lol

[midastouch017]

........then the Rabbi went back to the congregation.
The ones who screamed 'stand up' asked for his judgement.

'you are right' said the young Rabbi.

then the ones who screamed 'sit down' said 'Rabbi, it is our custom to side down'. The Rabbi said 'you are right'.

then a youngster said to him, 'Rabbi, you told the first group they were right, and you told the second group they were right too. that is a contradiction, they can't both be right!'.

and the Rabbi said to the child 'and you are right too'.

and then Rabbi Shlomo sat down to eat his bagel and lox ... and to this day he is known as 'Shlomo the Wise from Chelm ... err, Chicago'.

[mnfats]

A young scholar from New York was invited to become Rabbi in a small old community in Chicago.

On his very first Shabbat, a hot debate erupted as to whether one should or should not stand during the reading of the Ten Commandments.

The next day, the rabbi visited 98 year-old Mr. Katz in the nursing home.

"Mr. Katz, I'm asking you, as the oldest member of the community," said the rabbi, "what is our synagogue's custom during the reading of the Ten Commandments?"

"Why do you ask?" asked Mr. Katz.

"Yesterday we read the Ten Commandments. Some people stood, some people sat. The ones standing started screaming at the ones sitting, telling them to stand up. The ones sitting started screaming at the ones standing, telling them to sit down... "

"That," said the old man, "is our custom."

[midastouch017]

lol, it certainly seems so

[mnfats]

Did we have the same mother?????????

[midastouch017]

25 REASONS WHY I OWE MY MOTHER

1. My mother taught me TO APPRECIATE A JOB WELL DONE .
"If you're going to kill each other, do it outside. I just finished cleaning."

2. My mother taught me RELIGION.
"You better pray that will come out of the carpet."

3. My mother taught me about TIME TRAVEL .
"If you don't straighten up, I'm going to knock you into the middle of next week!"

4. My mother taught me LOGIC.
" Because I said so, that's why."

5. My mother taught me MORE LOGIC.
"If you fall out of that swing and break your neck, you're not going to the store with me."

6. My mother taught me FORESIGHT.
"Make sure you wear clean underwear, in case you're in an accident."

7. My mother taught me IRONY
"Keep crying, and I'll give you something to cry about."

8. My mother taught me about the science of OSMOSIS.
"Shut your mouth and eat your supper."

9. My mother taught me about CONTORTION ISM.
"Will you look at that dirt on the back of your neck!"

10. My mother taught me about STAMINA.
"You'll sit there until all that spinach is gone."

11. My mother taught me about WEATHER.
"This room of yours looks as if a tornado went through it."

12. My mother taught me about HYPOCRISY.
"If I told you once, I've told you a million times. Don't exaggerate!"

13. My mother taught me the CIRCLE OF LIFE..
"I brought you into this world, and I can take you out."

14. My mother taught me about BEHAVIOUR MODIFICATION.
"Stop acting like your father!"

15. My mother taught me about ENVY.
"There are millions of less fortunate children in this world who don't have wonderful parents like you do."

16. My mother taught me about ANTICIPATION..
"Just wait until we get home."

17. My mother taught me about RECEIVING .
"You are going to get it when you get home!"

18. My mother taught me MEDICAL SCIENCE.
"If you don't stop crossing your eyes, they are going to freeze that way."

19. My mother taught me ESP.
"Put your sweater on; don't you think I know when you are cold?"

20. My mother taught me HUMOUR.
"When that lawn mower cuts off your toes, don't come running to me.."

21. My mother taught me HOW TO BECOME AN ADULT .
"If you don't eat your vegetables, you'll never grow up."

22. My mother taught me GENETICS.
"You're just like your father."

23. My mother taught me about my ROOTS.
"Shut that door behind you. Do you think you were born in a barn?"

24. My mother taught me WISDOM.
"When you get to be my age, you'll understand."

25. And my favourite: My mother taught me about JUSTICE
"One day you'll have kids, and I hope they turn out just like you.

[mnfats]

I thought the most famous person was Ronald McDonald.

[midastouch017]

Our teacher asked us what our
favorite animal was, and I said, "Fried chicken."
She said I wasn't funny, but she couldn't have been right, because everyone else in the class laughed.

My parents told me to always be truthful and honest, and I am. Fried chicken is my favorite animal. I told my dad what happened, and he said my teacher was probably a member of PETA. He said they love animals very much.

I do, too. Especially chicken, pork and beef. Anyway, my teacher sent me to the principal's office. I told him what happened, and he laughed, too. Then he told me not to do it again.

The next day in class my teacher asked me what my favorite live animal was. I told her it was chicken. She asked me why, just like she'd asked the other children.

So I told her it was because you could make them into fried chicken.

She sent me back to the principal's office again. He laughed, and told me not to do it again. I don't understand. My parents taught me to be honest, but my teacher doesn't like it when I am.

Today, my teacher asked us to tell her what famous person we admire most.

I told her, "Colonel Sanders."

Guess where I am now...

[mnfats]

LOL I guess you know me better than I thought.

[genisi]

And I'm sure you enjoy some of the benefits

[mnfats]

Too funny!!!

[mnfats]

Joke or a miracle? lol

[mnfats]

I always knew I was a VIP.

[midastouch017]

Freeeeeedoooooooooooom!!!!

successful jail break!

http://i.imgur.com/Q83RB.gif

[midastouch017]

Joke of the year

Two women were sitting quietly together, minding
their own business.

[genisi]

Schizophrenia gene?

http://www.nih.gov/news/health/feb2011/nimh-23.htm

[mnfats]

LOL That's why I don't play the lottery. I'm a very happy man.

[midastouch017]

Lottery Winner Interview

<short and to the point>

[mnfats]

Just feed the croc a bunch of cabbage. That should do the trick. lol

[mnfats]

Maybe she was pregnant and the water bag broke.

[midastouch017]

CROC-o-DIAL: When Rimma Golovko reported to staff at an aquarium in
Ukraine that a crocodile had swallowed her cell phone, at first they
thought it was a crock. But when they heard the phone ringing from
inside the animal, they realized she was telling the truth. Apparently
Golovko had been using her mobile to try to snap a picture of the
reptile opening his mouth when the phone slipped from her hand and went
down the hatch. The crocodile, "Gena", may need surgery to remove the
phone. (JW/AP) ...Which will be scheduled as soon as the croc stops
following Captain Hook.

[midastouch017]

FAST DRIVER, SLOW LEARNER: "Police: Woman Issued
Three Speeding Tickets
in One Hour" -- WJW-TV headline

[mnfats]

Might be fun to give it a try and at my age I am really meaning TRY.
LOL