Here's my white paper on why the FDA will approve Otrexup:
Why Investors should feel confident with an FDA approval of Otrexup.
Pre-NDA / FDA submission studies:
• Human use and human factors usability studies produced
positive results.
• Studies showed Otrexup was safe and effective for RA patients w/ moderate to severe hand function impairment AND self administration of MTX using Antares Medi-Jet device is ALSO safe and well tolerated with virtually no pain.
• Completed successfully the final and most important clinical study necessary to support the NDA – study compared the relative systemic abailability of MTX following old method of administration to Sub Q self administration of Otrexup and the systemic availability of MTX increased proportionately at every dose, 5, 10, 20 and 25 milligrams.
• Several in place, new patent applications for Otrexup along with filing a trademark application with the USPTO for the brand name Otrexup.
• A Pre-(Otrexup) NDA meeting with the FDA resulted in awareness (oh, by the way!) of an additional treatment option – psoriasis.
• All clinical trials completed with positive results.
• Antares conducted a 4Q12 meeting with the FDA and reconfirmed regulatory pathway.
• Antares is proactive with the Agency.
• Head of the Otrexup program is Leroux Jooste, who previously in 1999, personally brought the DMARD Enbrel to market.
FDA / NDA filing:
• Completed. No refusal to file (RTF) from the FDA. No missing information experienced with the filing.
• Filing was accepted resulting in PDUFA October 14, 2013, no omissions of data or other deficiencies.
• Antares continues proactive FDA communications and Mid-cycle review with the FDA went “very well.”
• 6 ½ months have past, 3 ½ months left till approval and “no news (from the Agency) is good news.”
What is Methotrexate (MTX)?
• An already approved and marketed drug.
• Considered the “gold standard” or “foundation of RA treatment.”
• MTX is the most commonly prescribed (DMARD) in use today.
What are clinical trials and how do they relate to drug approval?
• Whether the drug has the effect it is suppose to have. (Confirmed by usability studies)
• How much of the drug to give to a patient and how often. (Confirmed 5, 10, 20 and 25 mg)
• What side effects are associated with the drug. (Safe and effective)
• How a drug is broken down in the body and how long it stays in the body. (Confirmed, safety and efficacy studies)
• Which foods, drinks, or other drugs can be used at the same time or should be avoided (contraindicated). (Confirmed, no treatment-emergent serious adverse events related to MTX)
• Clinical trials results allow the FDA to make decisions about whether or not a drug should be approved for marketing.
The first five bullet points have been satisfied by the clinical trials conducted by Antares and through the historical documentary on the already approved medicament, methotrexate. The sub Q delivery of the already approved drug, mtx, via Antares Medi-Jet device along with the positive, complete and thorough studies point to FDA approval for Otrexup and its marketing.
