The present invention relates to a vaginal drug delivery device configured to safely and effectively deliver a therapeutic formulation in the vagina at or near a desired target area for a specified time period.

Methods and compositions for treating or preventing C. difficile infections, particularly recurring C. difficile infections are described. The compositions for use in treating C. difficile include at least one agent that enhances a biological activity of interleukin-13 (IL-13), such as a recombinant IL-13 peptide or an agent that neutralizes the interleukin-13 (IL-13) decoy receptor, interleukin-13 receptor subunit alpha-2 (IL-13Ra2). Additionally or alternatively, the compositions can include a interleukin-4 (IL-4) peptide. The methods can result in more rapid recovery from CDI and decreased weight loss, e.g., than treatment without the neutralizing agent.

Methods and compositions for treating or preventing C. difficile infections, particularly recurring C. difficile infections are described. The compositions for use in treating C. difficile include at least one agent that enhances a biological activity of interleukin-13 (IL-13), such as a recombinant IL-13 peptide or an agent that neutralizes the interleukin-13 (IL-13) decoy receptor, interleukin-13 receptor subunit alpha-2 (IL-13Ra2). Additionally or alternatively, the compositions can include a interleukin-4 (IL-4) peptide. The methods can result in more rapid recovery from CDI and decreased weight loss, e.g., than treatment without the neutralizing agent.

A germinant mixture includes a) a bile acid main germinant, b) an amino acid co-germinant, c) an edible spore solubilizing agent, and d) a divalent metal salt co-germinant. Also described is an oral pharmaceutical composition including the germinant mixture and a pharmaceutically acceptable excipient. A method of treating, decolonizing, and/or preventing C. difficile infection in the gastrointestinal tract of a patient in need thereof includes orally administering the germinant mixture or the oral pharmaceutical composition and an antibiotic that is active against C. difficile to the patient in need thereof.

A germinant mixture includes a) a bile acid main germinant, b) an amino acid co-germinant, c) an edible spore solubilizing agent, and d) a divalent metal salt co-germinant. Also described is an oral pharmaceutical composition including the germinant mixture and a pharmaceutically acceptable excipient. A method of treating, decolonizing, and/or preventing C. difficile infection in the gastrointestinal tract of a patient in need thereof includes orally administering the germinant mixture or the oral pharmaceutical composition and an antibiotic that is active against C. difficile to the patient in need thereof.

The invention provides a topical o/w emulsion which moisturizes, and protects, repairs or restores the skin lipid barrier of a mammal. The topical o/w emulsion composition comprises: a) a discontinuous oil phase; b) a continuous aqueous phase comprising water; c) a thickening agent; d) at least one lamellar membrane structure comprising (i) a phospholipid, (ii) a fatty alcohol, and (iii) a fatty acid; e) a pharmaceutically acceptable active agent; and f) optionally a dermatologically acceptable excipient. In one embodiment, the composition, in use, has a water vapor transmission rate of less than or about 75 g.Math.m.sup.−2.Math.hr.sup.−1 measured in vitro using the modWVTR test methodology.

Disclosed are compositions comprising a polyene macrolide antibiotic and an azole antifungal, and packaged pharmaceutical products comprising the disclosed compositions. Also disclosed are methods of treating systemic fungal infections comprising co-administering to a mammal a polyene macrolide antibiotic and an azole antifungal (conjoint administration). The co-administration may be simultaneous (e.g., in a single formulation or in separate formulations), sequential, or staggered.

Disclosed are compositions comprising a polyene macrolide antibiotic and an azole antifungal, and packaged pharmaceutical products comprising the disclosed compositions. Also disclosed are methods of treating systemic fungal infections comprising co-administering to a mammal a polyene macrolide antibiotic and an azole antifungal (conjoint administration). The co-administration may be simultaneous (e.g., in a single formulation or in separate formulations), sequential, or staggered.

The invention described herein relates to therapeutic dosing regimens comprising administering venetoclax in combination with azacitidine and a CYP3A inhibitor for treating myelodysplastic syndromes (MDS).

The invention described herein relates to therapeutic dosing regimens comprising administering venetoclax in combination with azacitidine and a CYP3A inhibitor for treating myelodysplastic syndromes (MDS).