Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin, IFF flavor 316 282, Paracetamol, Pseudoephedrine
IFF flavor 316 282, Paracetamol, Phenylephrine, Guaifenesin · 2 trials · 1 indication
Intensity of warming sensation felt by subjects between predose to 1 minute postdose where 0 = no warming sensation and 100 = strongest possible warming sensation
Intensity of warming sensation felt by subjects between predose to 1 minute postdose where 0= no warming sensation and 100= strongest possible warming sensation
| Arm | Type | Description |
|---|---|---|
| Upper Respiratory Infections | EXPERIMENTAL | - |
| Upper Respiratory Tract Infection | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| IFF flavor 316 282, Paracetamol, Pseudoephedrine | DRUG | Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine |
| IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin | DRUG | Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup |
Inclusion Criteria: * Subject must have one or more symptoms per category (see also screening assessment of cold symptoms, section 6.1): * mild to moderate body pain, headache, fever or sore throat * nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing Exclusion Crit...
IFF flavor 316 282, Paracetamol, Pseudoephedrine is a small molecule combination being studied for the treatment of Upper Respiratory Infections (URTIs). It is formulated as a syrup containing paracetamol 500 mg and pseudoephedrine 30 mg, and is being developed by Novartis AG.
Novartis AG (ticker: NVS) is developing IFF flavor 316 282, Paracetamol, Pseudoephedrine. The drug is a small molecule combination syrup intended for patients with Upper Respiratory Infections.
IFF flavor 316 282, Paracetamol, Pseudoephedrine is in Phase 3 clinical development. It is an investigational drug and is not approved by the FDA. The Phase 3 trial has been completed.
IFF flavor 316 282, Paracetamol, Pseudoephedrine has one completed Phase 3 trial, NCT01586962, titled 'Warming Sensation Intensity and Acceptability of the Flavour, Local Tolerability of Paracetamol 500 mg + Pseudoephedrine 30 mg Syrup in Patients Suffering a URTI'. The trial enrolled 56 patients in Canada.
IFF flavor 316 282, Paracetamol, Pseudoephedrine is a combination product containing paracetamol 500 mg and pseudoephedrine 30 mg. The name includes the flavor identifier 'IFF flavor 316 282' to distinguish this specific formulation of the syrup.