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SYNTEX' INTRANASAL NAFARELIN FOR TREATMENT OF ENDOMETRIOSIS, PROSTATIC CANCER NEARING FDA SUBMISSION; NSAID TORADOL NDA PENDING, OPHTHALMIC FORM IN CLINICALS

Executive Summary

Syntex is planning to submit an NDA for nafarelin, and agonistic analog of gonadotropin-releasing hormone (GhRH) for treatment of endometriosis and prostatic cancer, within the next 18 months, the company declared in its annual report for fiscal 1986 (ended July 31). "Nafarelin is a synthetic compound which mimics a hormone naturally produced by the brain," Syntex stated. "In clinical trials with more than 400 women to date, nafarelin reduced the severity of endometriosis and was well-tolerated," the firm maintained. Noting that current drug therapy for endometriosis can cause side-effects such as facial hair, weight gain, edema, voice change and alterations in blood lipid levels, Syntex said nafarelin could have fewer long-term or unpleasant side effects if clinical trials continue to be successful. The compound utilizes a nasal drug delivery system. It is also being studied as a female contraceptive. Syntex has at least three NDAs already pending at FDA. The firm submitted an NDA for its prostaglandin Gardrin (enprostil) in January. An application for the calcium antagonist Cardene (nicardipine) for treatment of angina was submitted in 1985. Syntex also has an NDA pending for a nonsteroidal anti-inflammatory, Toradol (ketorolac), submitted recently for treatment of pain. In addition to the NDA for the tablet formulation of Toradol, said it expects to submit an NDA for an injectable form by the end of the fiscal year. The firm reported that "in clinical studies, the injectable formulation of Toradol has been shown to be as effective as either 12 mg of injectable morphine or 100 mg of Demerol without causing respiratory depression or constipation -- effects that are common to these and other opioid narcotic drugs." Syntex also claims a longer action for Toradol: six-hour duration of action vs. two to three hours for morphine and Demerol. In addition, Syntex stated that the drug "does not have the abuse or dependency potential associated with narcotic analgesics." An ophthalmic formulation of Toradol is also under development for treatment and possible prevention of aphakic cystoid macular edema (CME) in patients recovering from cataract surgery. Syntex said it plans to file applications for the formulation with FDA and foreign regulatory authorities in fiscal 1987. Nicardipine was reviewed by FDA's Cario-Renal Drugs Advisory Committee in September ("The Pink Sheet" Oct. 6, p. 7). The committee concluded that additional data showing the drug's efficacy beyond four hours was needed before nicardipine could be considered for approval. Syntex said it will submit the additional data "as quickly as possible." The firm also noted that it plans to file an NDA for use of the drug in hypertension in fiscal 1987. Key Pharmaceuticals is developing a sustained release, twice-a-day dosing formulation of nicardipine for Syntex, and DuPont Critical Care is developing and will market an I.V. formulation. Among 28 compounds Syntex has in preclinical and clinical trials, the annual report also highlights progress with lonapalene, a nonsteroidal topical preparation for treatment of psoriasis; ticlopidine, a platelet-aggregation inhibitor for prevention and treatment of stroke; and Cytovene, Syntex' version of the antiviral ganciclovir or DHPG, for potential treatment of AIDS and immune-suppressed organ transplant patients. Syntex said more than 800 people have participated in trials for its anti-psoriatic agent lonapalene. In early clinicals, Syntex stated, "more than 70% of patients have had a good response, with about half having their skin lesions cleared." The company's largest clinical trial in its history involves ticlopidine. Syntex said the 3,000th patient was enrolled in an ongoing trial in fiscal 1986. An additional 900 patients are also enrolled in an "advanced clinical study" investigating the potential for ticlopidine to prevent the occurrence of a second stroke. Trials are also underway to study ticlopidine in treating other cardiovascular diseases. With regard to Cytovene, Syntex reported that the drug "appears to stop the spread of cytomegalovirus by selectively inhibiting the synthesis of viral deoxyribonucleic acid." The company said more than 600 patients in over 50 hospitals throughout the U.S. have received Cytovene when they were in danger of losing their lives or eyesight from CMV infections and "two-thirds or more" have shown "significant clinical improvement." The drug was designated an orphan treatment by FDA in 1985. Burroughs Wellcome is also developing a version of ganciclovir. Syntex reports that its share of the oral contraceptive market in the U.S. exceeded 10% in the 12 months ended July 31 and that sales increased 12% to $86 mil. The company attributed most of the growth to sales of its triphasic oral contraceptive Tri-Norinyl. Syntex added that news reports of a study indicating there was no relationship between use of the pill and breast cancer, combined with the market withdrawal of most commonly prescribed intrauterine contraceptive devices, "is presumed to be partially responsible for strong growth in the total market for oral contraceptives." Naprosyn (naproxen) became the leading prescription NSAID worldwide for the first time in the quarter ended in March 1986. The company reported that Naprosyn and Anaprox (naproxen sodium) were marketed for new indications and in new formulations and dosage regimens in 21 foreign countries during fiscal 1986. A sustained release naproxen formulation was introduced in New Zealand, the first market for the formulation. Naproxen was also approved in Norway for prevention and treatment of migraine headaches. An NDA for that indication is pending in the U.S. Naprosyn NDAs are also pending for treatment of juvenile rheumatoid arthritis and for suspension and suppository formulations. An NDA for an Anaprox/codeine combination tablet for treatment of mild to moderate pain is also pending at FDA.
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