Streamlining nonclinical drug development using the FDA 505(b)(2) new drug application regulatory pathway

Salminen, William F.; Wiles, Marc E.; Stevens, Ruth E.

doi:10.1016/j.drudis.2018.07.005

Cited by 16 publications

(7 citation statements)

References 1 publication

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“…Salminen, Wiles and Stevens summarised in a review the nonclinical requirements for 505(b)(2) NDAs; however, they conclude that the nonclinical requirements are highly drug product-dependent [255]. For example, the question whether additional studies are needed for efficacy evaluation depends on the product's use.…”

Section: Preclinical Considerationsmentioning

confidence: 99%

Intranasal drug delivery: opportunities and toxicologic challenges during drug development

Keller

Merkel

Popp

2021

Drug Deliv. and Transl. Res.

297

178

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Over the past 10 years, the interest in intranasal drug delivery in pharmaceutical R&D has increased. This review article summarises information on intranasal administration for local and systemic delivery, as well as for CNS indications. Nasal delivery offers many advantages over standard systemic delivery systems, such as its non-invasive character, a fast onset of action and in many cases reduced side effects due to a more targeted delivery. There are still formulation limitations and toxicological aspects to be optimised. Intranasal drug delivery in the field of drug development is an interesting delivery route for the treatment of neurological disorders. Systemic approaches often fail to efficiently supply the CNS with drugs. This review paper describes the anatomical, histological and physiological basis and summarises currently approved drugs for administration via intranasal delivery. Further, the review focuses on toxicological considerations of intranasally applied compounds and discusses formulation aspects that need to be considered for drug development. Graphical abstract

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Section: Preclinical Considerationsmentioning

confidence: 99%

Intranasal drug delivery: opportunities and toxicologic challenges during drug development

Keller

Merkel

Popp

2021

Drug Deliv. and Transl. Res.

297

178

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“…The development of an antibiotic eye drop that has similar efficacy with once a day dosing compared to three times per day dosing would also be clinically impactful. Reformulation of a drug at the same concentration or lower than the approved concentration is a relatively straightforward path to clinical development 47 . Importantly, this approach is amenable to a variety of other water‐soluble ionizable drugs used to treat glaucoma, dry eye disease, and inflammation, among others, suggesting broad potential impact.…”

Section: Discussionmentioning

confidence: 99%

“…Reformulation of a drug at the same concentration or lower than the approved concentration is a relatively straightforward path to clinical development. 47 Importantly, this approach is amenable to a variety of other water-soluble ionizable drugs used to treat glaucoma, dry eye disease, and inflammation, among others, suggesting broad potential impact. Proparacaine eye drops were obtained from Bausch and Lomb Inc.…”

Section: Topically Administered Mox-pam Ns Provides Increased Intraoc...mentioning

confidence: 99%

An ion‐paired moxifloxacin nanosuspension eye drop provides improved prevention and treatment of ocular infection

Josyula

Omiadze

Parikh

et al. 2021

Bioengineering & Transla Med

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There are numerous barriers to achieving effective intraocular drug administration, including the mucus layer protecting the ocular surface. For this reason, antibiotic eye drops must be used multiple times per day to prevent and treat ocular infections. Frequent eye drop use is inconvenient for patients, and lack of adherence to prescribed dosing regimens limits treatment efficacy and contributes to antibiotic resistance.Here, we describe an ion-pairing approach used to create an insoluble moxifloxacinpamoate (MOX-PAM) complex for formulation into mucus-penetrating nanosuspension eye drops (MOX-PAM NS). The MOX-PAM NS provided a significant increase in ocular drug absorption, as measured by the area under the curve in cornea tissue and aqueous humor, compared to Vigamox in healthy rats. Prophylactic and treatment efficacy were evaluated in a rat model of ocular Staphylococcus aureus infection. A single drop of MOX-PAM NS was more effective than Vigamox, and completely prevented infection. Once a day dosing with MOX-PAM NS was similar, if not more effective, than three times a day dosing with Vigamox for treating Aditya Josyula and Revaz Omiadze contributed equally to this study.

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“…It requires the generation of necessary pre-clinical or clinical data suggested by the FDA agency. 48 As per the FDA guidance, the cocrystals are considered analogous to the polymorphs. Therefore, the present case ["Niraparib tosylate L-proline" which is a cocrystal of the marketed drug "Niraparib tosylate"] can be submitted as 505(j) application to the FDA.…”

Section: Crystengcomm Papermentioning

confidence: 99%

A zwitterionic salt–cocrystal: in vitro insights from niraparib tosylate, an anti-cancer drug

Mudda,

Devarapalli,

Das

et al. 2024

CrystEngComm

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Streamlining nonclinical drug development using the FDA 505(b)(2) new drug application regulatory pathway

Cited by 16 publications

References 1 publication

Intranasal drug delivery: opportunities and toxicologic challenges during drug development

Intranasal drug delivery: opportunities and toxicologic challenges during drug development

An ion‐paired moxifloxacin nanosuspension eye drop provides improved prevention and treatment of ocular infection

A zwitterionic salt–cocrystal: in vitro insights from niraparib tosylate, an anti-cancer drug

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