FDA Application for Orphan Drug Designation , PAA, MPL, page-253

That's certainly within the realm of play Jock , sometimes it's not "what Big Pharma may gain" but "What Big Pharma Might Lose" by not taking up a New Treatment..

Pfizer is pulling $1.2B p/a currently from Riluzole and that Drug has "Significant Adverse Effects"

From The FDA Site ,,, Remember this is an FDA Approved Treatment.."$1.2B"

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

1. Bladder pain
2. bloody or cloudy urine
3. blurred vision
4. chills
5. cough
6. dark urine
7. diarrhea
8. difficult, burning, or painful urination
9. fast, pounding, or irregular heartbeat or pulse
10. fever
11. frequent urge to urinate
12. general feeling of discomfort or illness
13. headache
14. increased cough
15. itching skin
16. joint pain
17. loss of appetite
18. lower back or side pain
19. muscle aches and pains
20. nausea
21. nervousness
22. persistent loss of appetite or weight loss
23. pounding in the ears
24. right upper quadrant tenderness
25. runny nose
26. shivering
27. slow heartbeat
28. sore throat
29. trouble sleeping
30. unusual tiredness or weakness
31. vomiting
32. yellow eyes or skin

Incidence not known

1. Black, tarry, stools
2. decreased frequency or amount of urine
3. difficult breathing
4. increased thirst
5. nausea
6. pale skin
7. swelling of the face, fingers, or lower legs
8. ulcers, sores, or white spots in the mouth
9. unusual bleeding or bruising
10. weight gain

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

1. Agitation
2. back pain
3. bluish-colored lips, fingernails, or palms
4. blurred vision
5. coma
6. confusion
7. dark urine
8. difficulty breathing
9. dizziness or lightheadedness
10. drowsiness
11. fever
12. headache
13. irritability
14. memory loss
15. pale skin
16. rapid heart rate
17. seeing, hearing, or feeling things that are not there
18. seizures
19. sore throat
20. stiff neck
21. unusual bleeding or bruising
22. unusual tiredness or weakness
23. vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

1. Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
2. lack or loss of strength

Less common

1. Difficulty moving
2. dizziness or lightheadedness
3. dry mouth
4. excess air or gas in the stomach or bowels
5. feeling of constant movement of self or surroundings
6. full feeling
7. muscle stiffness
8. passing gas
9. rapid weight gain
10. sensation of spinning
11. skin rash, encrusted, scaly and oozing
12. sleepiness or unusual drowsiness
13. stomach pain
14. tingling of the hands or feet
15. unusual weight gain or loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

MPL Adverse effects listed Below.....................................














MPL for the Treatment of MND