Dutasteride: motivazioni del ritardo e doc sugli effetti col

[Lottatore]

Allora,

 

il sito www.dutasteride.com finalmente ha dato degli aggiornamenti interessanti.

 

Innanzitutto vi posto la news in cui si spiegano, o meglio si provano a spiegare i motivi del ritardo della sua uscita. Come potrete vedere sono molto semplici, legati al lancio, ad esempio l'approvazione del NOME del farmaco dalla FDA e' cosa non semplice, il nome DUAGEN era simile ad un altro farmaco che era niente popodimeno che ... una pillola anticoncezionale ! Roba da matti, sfxxx nella sfxxx, il fatto che qualche medico o paziente si confondesse con i nomi avrebbe portato magari una donna ad assumere duta tutti i giorni pensando fosse la pillola !!!!

 

Per quel che rigurda tutti coloro preoccupati sugli effetti collaterali, consiglio di guardare ancora nelle news del sito a questo indirizzo:

http://www.fda.gov/cder/foi/nda/2001/21319...agen_pharmr.pdf

 

dove potrete leggere il report su dosi somministrate nei test sugli animali a 1000 o 1000 volte superiori a quella somministrata sugli umani di 0.5 mg al giorno.

 

A volte basta un'ora passata a leggere un documento x liberarsi di tutti i fantasmi che aleggiano sulla rete.

 

Le motivazioni sono tutte riconducibili ad un problema del lancio del farmaco, ed al fatto che sicuramente Glaxo non vuole correre nel fiasco di un prodotto in cui ha gia' investito milioni di dollari, deve trovare il modo di surclassare la finasteride in tutta sicurezza.

 

I pareri sono benvenuti.

 

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January 28, 2002 - Hair loss sufferers are understandably frustrated by the delay in obtaining Dutasteride after its recent approval by the FDA. On November 21, 2001 Dutasteride received approval as a new drug and was expected to be released within a month or so. As it now turns out it may only be released by the middle to the end of 2002. That is assuming all goes well with what is causing the delay.

 

Hairlosshelp.com has done some research to determine why there is a delay and has found several reasons for it.

 

Brand Name issue

 

In a call last week to our contact at Glaxo we were informed that a name still has not been selected for the drug. It is unclear if Glaxo has submitted several names to the FDA and they have approved them all and Glaxo is deciding which one to use, or if they are still waiting for the FDA to approve them.

 

The brand name of a drug, like any other product, is extremely important in terms of brand recognition. It takes a lot of time to find a suitable name that has not already been trademarked by someone else. To further complicate things for a drug company, once the name has been selected and trademarked, it still has to be approved by the FDA. The reason for this is very simple. If there are other drugs with similar names, there is a chance that the wrong drug may be incorrectly dispensed when the prescription is given to a pharmacist. This is a very real problem and does happen from time to time and in some cases the mistakes are fatal.

 

This is what happened with the two names Glaxo initially submitted, Zygara and Duagen. Zygara was rejected because it was too close to the name of a drug called Zyprexa, and Duagen was rejected because it was too close in name to the oral contraceptive, Desogen.

 

Metabolism issue

 

In Glaxo's clinical studies they were only able to account for 45% of the drug in the body, which means they were unable to determine how the remaining 55% was metabolized by the body. This raised some red flags at the FDA and they requested that Glaxo do a Phase 4 study, which is really an additional year of data following the same subjects. Dr Al-habet, who was one of the medical reviewers on the panel that approved Dutasteride, raised this concern and requested the additional data.

 

The committee recommended that Glaxo submit Phase 4 test results (2nd year study data), which is what the sNDA is for. In the meanwhile the FDA has mandated that Dutasteride have warnings about interactions with a whole class of drugs because it's unclear how Dutasteride will interact with these other drugs, particularly those metabolized by the liver like Ketokonazole. These stricter warnings in effect would limit the market since many of the patients who are using Dutasteride for its intended purpose are older men. Since it was approved as a prostate drug many users who are in the age group who experience BPH may also be on other medications that may interact with Dutasteride and they would be unable to use this drug.

 

From a marketing standpoint this would be problematic and potentially disastrous and could ruin the efforts of the marketing department. The drug sales reps would have to convince doctors to switch their patients from Proscar (Finasteride), which has a proven track and safety record, to a brand new drug that still has some safety concerns. It would understandably make it easier to sell if the sNDA was approved and the FDA required fewer restrictions on labeling, assuming that there were no further concerns about its safety.

 

In fact Glaxo made the following agreement with the FDA. If the FDA approved its NDA application without a trademark they would then submit new brand names along with their Phase 4 data (sNDA application).

 

So it appears the delay is very real and relevant. Without an approved name Glaxo cannot market their product, and without approval of the sNDA, there will be restrictions placed on their labeling that will limit its potential market. Since Glaxo is a business that has invested millions of dollars on developing this drug, it makes perfect sense for them to wait the few extra months for the FDA to approve their 2-year study data.

 

In terms of the names for the drug, the most likely brand name will either be Avolve, or Avodart, both of which have recently been trademarked by Glaxo for prostate drugs.

 

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[smxs]

Si ma quando esce!